CTRI Number	CTRI/2021/10/037699 [Registered on: 29/10/2021] Trial Registered Prospectively
Last Modified On:	11/09/2024
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Drug
Study Design	Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study	A Phase IIb/III clinical trial to assess the safety and efficacy of study drug, CA-170 in combination with standard chemotherapy in stage IV lung cancer patients.
Scientific Title of Study	A Phase IIb/III, Randomised, Double-blind, Placebo-controlled, Multicentre, Study of CA-170 in Combination with Chemotherapy in Patients with Stage IV Non-Squamous Non-Small Cell Lung Cancer (ASIAD-3)
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Dr Akhil Kumar  Address  A39-40, KIADB Industrial Area, Phase II, Electronic City Hosur Road (Subsidiary of Dr. Reddys Laboratories limited) Bangalore Bangalore KARNATAKA 560100 India  Phone  9632203510   Fax     Email  Akhil_k@aurigene.com
Details Contact Person Scientific Query	Name  Dr Manjunath Krishnappa  Address  A39-40, KIADB Industrial Area, Phase II, Electronic City Hosur Road (Subsidiary of Dr. Reddys Laboratories limited) Bangalore Bangalore KARNATAKA 560100 India  Phone  9825418034   Fax     Email  manjunath_k@aurigene.com
Details Contact Person Public Query	Name  Shilendra Pandey  Address  A39-40, KIADB Industrial Area, Phase II, Electronic City Hosur Road (Subsidiary of Dr. Reddys Laboratories limited) Bangalore Bangalore KARNATAKA 560100 India  Phone  9873554523   Fax     Email  shilendra_p@aurigene.com
Source of Monetary or Material Support	Aurigene Discovery Technologies Limited, 39-40, KIADB Industrial Area Phase II Electronic City Hosur Road Bangalore 560 100 Karnataka India
Primary Sponsor	Name  Aurigene Discovery Technologies Limited   Address  A subsidiary of Dr. Reddys Laboratories Limited 39-40, KIADB Industrial Area Phase II Electronic City Hosur Road Bangalore 560 100 Karnataka India   Type of Sponsor  Pharmaceutical industry-Indian
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 79   Contact Person  Name of Site  Site Address  Phone/Fax/Email  DrNikhil Mallinath Shirsi  7 Orange Hospital  Pawana Nagar, next to Jain School, near Chapekar Chowk, Chinchwad, Maharashtra 411033, India Pune   7835826155 drnikhilshirsi@gmail.com  Dr Mukesh Choudhary  Abhishek Hospital  3 B III, near Dharam Singh Circle, Moti Doongri Rd, Tilak Nagar, Jaipur, Rajasthan 302004 Jaipur   9829251085 mukeshchoudharydm@gmail.com  Dr Sameeksha Dubey  Acharya Vinoba Bhave Rural Hospital  Datta meghe institute of Higher Education and Research, Sawangi, Wardha, Maharastra-442001 Wardha   9892670749 drsameekshadubey@gmail.com  Dr Deepam Pushpam  AIIMS  AIIMS New Delhi, Dr. BR Ambedkar Institute Rotary Cancer Hospital. AIIMS, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 New Delhi   9650629370 deepampushpam@gmail.com  Dr Vandana Singh Kushwaha  AIIMS Nagpur  AIIMS Nagpur, Department of Radiotherapy, Plot No. 2, Sector 20, Miham, Nagpur, Maharashtra 441108 Nagpur   9405744685 drvandana.radonco@gmail.com  Dr Sunu Cyriac  Amala Institute of Medical Sciences  Amala institute of Medical Science Amala nagar Thrissur Kerala - 680555 Thrissur   9778425563 drsunucyriac555@gmail.com  Dr Satyanker Gupta  American Oncology Institute  Acharya Shri Chander College of Medical Sciences ASCOMS, By-Pass Road, Sidrah, Jammu, Jammu and Kashmir 180017. Jammu   9469938223 gupta.satyanker@gmail.com  Dr Wesley M Jose  Amrita Institute of Medical Sciences   AIMS Ponekkara P.O, Kochi, Kerala 682041, India. Ernakulam   8281928375 wesleymjose@aims.amrita.edu  Dr Shailesh Bondarde  Apex Wellness Hospital   SNO 787, P NO. 52, Govind Nagar, Nashik, Maharashtra - 422009 Nashik   9822012427 shaileshbondarde1971@gmail.com  Dr Puneet Gupta  Asian Institute of Medical Sciences  Badkal Flyover Road, Sector 21-A, Faridabad-121001, Haryana, India. Faridabad   9810036915 Pgcancer@gmail.com  Dr Prashant Pandey  B P Poddar Hospital & Medical Research Ltd  B P Poddar Hospital & Medical Research Ltd 71/1, Humayun Kabir Sarani, Block G, New Alipore, Kolkata, West Bengal 700053 Kolkata   9804290687 2drprashant@gmail.com  Dr MVT Krishna Mohan  Basavatarakam Indo American Cancer Hospital & Research Institute  Road No. 10, IAS Officers Quaters, Nandi Nagar, Banjara Hills, Hyderabad, Telangana 500034 Hyderabad   9866154503 mvtkm@yahoo.com  Dr Tanmoy Kumar Mandal  Binayak Multi-specialty Hospital  Binayak Multi-specialty Hospital, Binayak Enclave,59, Kali Charan Ghosh Road, Kolkata Kolkata   9051238499 tanmay.nrs@gmail.com  Dr Shishir Shetty  Cancure Health Care LLP  Cancure Day Care Centre, Father Agnel College Sector-9A, Next to Noor Masjid, Vashi, Navi Mumbai 400703 Mumbai   9920852145 cancare1@gmail.com  Dr Deepak Koppaka  Care Hospital  Hi-tech city, Hyderabad- 500034, India Hyderabad   9052289998 drdeepak.koppaka@gmail.com  Dr Rakesh Chaudhary  Chandan Hospital  Faizabad Road, Near Chinhat Flyover, Vijayant Khand, Gomtinagar, Lucknow-226010 Lucknow   6391990013 drrakesh8188@gmail.com  Dr Bidisha Ghosh  Charnock Hospital  Charnock Hospital Building No 4, OPD Section, Ground floor p BMC 195, Teghoria, Biswas Bangla Sarani, Kolkata 700157 Kolkata   9831639000 info@charnackhospital.com  Dr Chetan Deshmukh  Deenanath Mangeshkar Hospital and Research Centre  Deenanath Mangeshkar Hospital Road, near Mhatre Bridge, Erandwane, Pune, Maharashtra 411004 Pune   9850811449 drchetandeshmukh@gmail.com  Dr Sri Krishna Mondal   Department of Radiotherapy, Nil Ratan Sircar Medical College and Hospital   138, AJ Bose road Kolkata -700014 Kolkata   9830648931 mondal_srikrishna@reddiffmail.com  Dr Sandeep Jasuja  Dept of Medical Oncology, SMS Hospital  Dept of Medical Oncology, SMS Hospital, JLN Marg,Jaipur, Jaipur, Rajasthan 302004, India. Jaipur   9660121475 sandeepjasuja@gmail.com  Dr K M Parthsarthy  Dharamshila Narayana Superspeciality Hospital  Dharamshila Narayana Superspeciality Hospital, Vasundhara Enclave , Near New Ashok Nagar Metro Station,Dallupura, New Delhi, Delhi - 110096 East   9810367424 drparth@hotmail.com  Dr Sajjan Raj Purohit  Dr. B.L. Kapur Memorial Hospital  Pusa Road, New Delhi-110005, India. New Delhi   9999660200 sajjanrajpurohit@yahoo.com  Dr R Suresh Kumar  Erode Cancer Centre  Erode Cancer Centre, no. 1/393,Velavan Nagar,Perundurai Road,Thindal., Erode, Tamil Nadu - 638012 Erode   9487018787 drrsk21@gmail.com  DrRajat Bajaj  Fortis Hospital Limited  B-22, Sector 62, Noida, Uttar pradesh 201301, India. Gautam Buddha Nagar   1204300222 rajat.bajaj@iosplcancer.com  Dr Amit Agarwal  Fortis Hospital Shalimar Bagh  Fortis Hospital Shalimar Bagh, A Block, Delhi-110088, India. North East   9971611311 amit.agarwal@fortishealthcare.com  Dr Uma Bhaskar Dangi  Fortis Hospitals limited   Fortis Hospitals limited, Mulund Goregaon link road, Bhandup-west, Mumbai, Maharashtra 400078, India. Mumbai   9820157064 dr.uma04@gmail.com  Dr Amit Trilokinath Bhargava  Fortis Hospitals limited Faridabad  Neelam Bata Road, Faridabad, Haryana 121001 India Faridabad   9811065538 amitbhargava.tp@fortishealthcare.com  Dr Ashwin Rajbhoj  Global Hospital & Research Institute  577/2, off Sinhgad Road, Police Chaoki Rd, near Dattawadi, Dattawadi, Pune, Maharashtra 411030, India. Pune   8793398680 drashwinrajbhog@gmail.com  Dr Javvid Muzamil  GMC Srinagar Super Speciality Hospital  GMC Srinagar Super Speciality Hospital Bemina, Srinagar, Jammu and Kashmir 190010. Srinagar   7006707372 javvidmd@gmail.com  Dr Minish Jain  Grant Medical Foundation Ruby Hall Clinic  Grant Medical Foundation Ruby Hall Clinic,40, Sassoon Road, Pune-411001, Maharashtra Pune   9823133390 minishjain009@gmail.com  Dr Jayanti Patel  Gujarat Hospital – Gastro and Vascular Centre  Gujarat Hospital – Gastro and Vascular Centre, Anand Mahal Rd, Opposite Shree Ram Petrol Pump, Girinagar Society, Muktanand Nagar, Adajan, Surat, Gujarat 395009 Surat   9825121347 pateldrjayanti@gmail.com  Dr Akash Patel  HCC Multispeciality Hospital LLP  HCC Multispeciality Hospital LLP. 302, 303, 305 &407 Shital Varsha Mall -5 Shivranjani Cross Road, Satellite Ahmedabad, Gujarat 380015 Ahmadabad   9601987566 drakash.cr@gmail.com  Dr Nandish Kumar  HCG Cancer Centre  "HCG Cancer Center, No.1-10/A, 1-10 Khuba Plot, Station Road, Gulbarga, Karnataka- 585 102. Gulbarga   7259029517 docnandishkumar@gmail.com  Dr Satheesh C T  HCG Cancer Centre   HCG Towers, Tower-I, 1st floor,#8 P. Kalinga Rao Rd, Sampangi Rama Nagara, Bengaluru, Karnataka 560027 Bangalore   9242698750 drsatheeshct@gmail.com  Dr Lakshmi Priyadarshini  HCG City Cancer Centre  35-25-33, Ch Venkata Krishnayya Street, Suryarao pet, Vijayawada-520002, Andhra Pradesh Krishna   9502945399 priyadarshini009@gmail.com  Dr Rajnish Nagarkar  HCG Manavata Cancer Centre  Behind Shivag Auto, Mumbai Naka, Nashik 422002, Maharastra, India Nashik   9823061929 drraj@manavatacancercentre.com  Dr Vishal Kulkarni   HCG NMR Cancer Centre   Deshpande Nagar Hubli-580029 Dharwad   8660434729 drvishal.k@hcgel.com  Dr Sanjiv Kumar Verma  Himalayan Institute of Medical Science, Swami Rama Himalayan University  Himalayan Institute of Medical Science, Swami Rama Himalayan University, Swami Ram Nagar, Jolly Grant, Dehradun, Uttarakhand 248016 Dehradun   9837121136 skverma177@gmail.com  Dr Lalatendu Moharana  IMS and SUM Hospital  K-& Kalinga Nagar, Ghatikia, Bhubaneswar-751003, Odisha, India. Khordha   9538752579 drlalatendu@gmail.com  Dr Sanjay Pillani  Jahangir Clinical Development Centre Private Ltd  Jahangir Hospital premises, 32 Sasson road, Pune-411001, Maharastra Pune   9146559989 honeypiplani@gmail.com  Dr Mukesh S  K R Hospital, Mysore Medical College & Research Institute and Associated Hospitals  K R Hospital, Department of Oncology, K R Hospital, Mysore Medical College & Research Institute and Associated Hospitals, Irwin Road, Mysore-570021, Mysore   9886873788 dal_muk1@hotmail.com  Dr Niraj Bhatt  Kailash Cancer Hospital and Research Center   Muniseva Ashram, Goraj, Waghodia, Vadodara - 391760 Vadodara   2668265300 niraj.bhatt@greenashram.org  Dr Sudhir Singh  KGMU  Shah Mina Rd, Chowk, Lucknow, Uttar Pradesh 226003 India Lucknow   7499737814 drsudhirsaharanpur@gmail.com  Dr Saurabh Prasad  Kims Kingsway Hospitals  Kingsway Hospital, 44, Kingsway, Near Kastur Chand Park, Nagpur-440001, Maharashtra India Nagpur   7066580511 drsaurabhprasad@gmail.com  Dr Anshul Agarwal  Kiran Hospital Multi Super Speciality Hospital and Research Center  Kiran Hospital Multi Super Speciality Hospital and Research Center, near sumul dairy, Surat Surat   8657068668 anshul.onco@gmail.com  Dr Mahesh Kalloli  KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre,   KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre, NH Service Road, Basava Circle, Chikodi, Nehru Nagar, Belgaum, Karnataka 590010 Belgaum   9945014996 mahesh.kalloli@gmail.com  Dr Suraj Pawar  Kolhapur Cancer Centre  Kolhapur Cancer Centre, R.S.No. 238, opp. Mayur Petrol Pump, Gokul Shirgaon, Kolhapur, Maharashtra - 416234 Kolhapur   9822014908 surajpawar2001@yahoo.co.in  Dr Viraj Vijay Borgaonkar  Krupamayi Hospital  Akshay Opp. Youth hostel, Near Baba Petrol Pump, station road, Aurangabad, Maharashtra, India.-431001 Aurangabad   9673073555 viraj.oncosurg@gmail.com  Dr Koushik Chatterjee  Lifeline Diagnostics Centre cum Nurshing Home  4A, wood Street, Kolkata-700016, India. Kolkata   9874357580 drkoushikchatterjee@gmail.com  Dr Rajani Priya Yadla  Mahatma Gandhi Cancer Hospital and Research Institute  Mahatma Gandhi Cancer Hospital and Research Institute, 1/7, M.V. P. Colony, Visakhapatnam- 530017, Andhrapradesh, India. Visakhapatnam   7702086187 priyadrrajini@gmail.com  Dr Manu Prasad  Malabar Cancer Centre  Malabar Cancer Centre, Mozhikara-670103, Thalassery, Kerala, India. Kannur   4902355881 manuprasadmcc@gmail.com  Dr Ekta Vala  Medisquare Hospital & Research Institute  Medisquare Hospital & Research Institute O-201, 202, Gala Empire, Opp. Doordarshan Tower, Drive-in road, Gurukul, Ahmedabad-380052, Gujarat. Ahmadabad   8238034088 ektavala89@gmail.com  Dr K S Kirushna Kumar  Meenakshi Mission Hospital and Research Centre  Meenakshi Mission Hospital and Research Centre Lake area, Melur road, Madurai, Tamilnadu, 625107 Madurai   9842113003 dr.kskk@yahoo.com  Dr Parimkayala Radhika  MNJ Institute of Oncology & Regional Cancer Centre  MNJ Institute of Oncology & Regional Cancer Centre Old Building, 3rd floor, Clinical Trial Room No.11, Red Hills, Hyderabad, Telangana- 500004, India. Hyderabad   9848792682 radhika.parimkayala@gmail.com  Dr Anupam Datta  Netaji Subhash Chandra Bose Hospital  #3081, Nayabad New Garia, Kolkata- 700094, India Kolkata   9163067435 dranupamdatta@gmail.com  Dr Rachan Shetty  Omega Hospital   Omega Hospital Mahaveer Circle, Kankanady, Mangalore, Karnataka, 575002 Dakshina Kannada   9008753317 drrachanshetty.medoncology@gmail.com  Dr Ravishankar  Omega Hospitals  Plot no-04, Chinna Gadhili, Hanumanthavaka, Visakhapatnam, Andhra Pradesh 530040. Visakhapatnam   8555976042 dr.bellabravishankar@gmail.com  Dr Anil Kumar M R  Oncoville Cancer Hospital and Research Centre  Oncoville Cancer Hospital and Research Centre, No. 04, 80 feet Road, 7th Block, Nagarabhavi, 2nd Stage, Bengaluru- 560072 Bangalore   7349490345 dr.anilonco@gmail.com  Dr Pawan Kumar Singh  Pandit Bhagwat Dayal Sharma Post Graduste Institute of Medical Sciences  Pt BDS PGIMS Medical Rd, Rohtak, Haryana 124001 Rohtak   8437013094 ga.ps.complete@gmail.com  Dr Ankolikar Shrikant   PDEAs Ayurved Rugnalaya and Sterling Multi-speciality Hospital   Sector No.27 Behind Sweet Junction, Nigdi, Pradhikaran, Pune -411044 Pune   9527239023 ankolikarshrikant@gmail.com  Dr Anuj Kumar Bansal  Punjab Cancer Care Multispeciality Hospital  Punjab Cancer Care Multispeciality Hospital Z-3-03570, Goniana Road, opp. Dayal Kidney Hospital, Near Tinkoni, Bathinda , Punjab-151001 Bathinda   8728840999 anujkumarbansal2003@gmail.com  Dr Vikas Talreja  Regency Hospital Ltd  A-4 Tower 2, Sarvoday Nagar, Kanpur, Uttar Pradesh, 208005 Kanpur Nagar   9769890961 vikasttalreja@gmail.com  Dr VArun Ramanan  Royapettah Government Hospital, Chennai   1, West Cott Road, Royapettah, Chennai, Tamil Nadu 600014 Chennai   994287553 drarmv@rediffmail.com  Dr Mukesh Bang  RST Cancer Hospital and Research Centre  RST Cancer Hospital and Research Centre Tukdoji Sqaure, Manewada Road, Nagpur 440027, Maharashtra, India Nagpur   9922869635 drmukeshbang31@gmail.com  Dr Pratik Patil  Saikrupa Hospital  Saikrupa Hospital Plot no 4/14/B, Sect. no 34, Renuka Corner, Tapkir Chowk, Thergaon, Pune 411033, Maharashtra Pune   9637439163 pratikpatil79@rediffmail.com  Dr Aniket Thoke  Sanjeevani CBCC USA Cancer Hospital  In front of Jain Mandir, near Ram Krishna Care Hospital, Davda Colony, Pachpedi Naka, Raipur, Chhattisgarh 492001 Raipur   9634321525 drthoke@gmail.com  Dr Bhushan Nemade  Sankalp Speciality Hospital  Mumbai - Agra National Hwy, behind Chhan Hotel, Mumbai Naka, Vallabh Nagar, Nashik, Maharashtra 422009 Nashik   9766126162 drbtnemade@yahoo.com  Dr Nataraj Y S  Sapthagiri Institute of Medical Sciences and Research Centre  Sapthagiri Institute of Medical Sciences and Research Centre, #15, Chikkasandra, Hesaraghata Main Road, Blr- 560090 Bangalore   9448216837 reachnatts0879@gmail.com  Dr Jignesh Kumar Rajvanshi  Shailya Hospital  Shailya Hospital, 2nd Floor, Stadium Plaza, Sardar Patel Stadium Rd, Naranpura, Ahmedabad 380013, Gujarat, India Ahmadabad   9727701904 jignesh.doctor7@gmail.com  Dr Syed Nisar  Sher -i- Kashmir Institute of Medical Sciences  Sher -i- Kashmir Institute of Medical Sciences, Soura, Srinagar, Jammu & Kashmir - 190011 - India Srinagar   9469664186 syednisaronco11@gmail.com  Dr Surender Kr Beniwal  SP Medical College & AG of Hospitals  SP Medical College & AG of Hospitals, Department of Medical Oncology RCC, Bikaner, Rajasthan- 334003 Bikaner   9782300231 beniwal.surendra@gmail.com  Dr Ghanshyam Biswas  Sparsh Hospital and Critical care  Sparsh Hospital, A/407, Saheed Nagar, Bhubaneswar, Odissa-751007, India. Khordha   9937500878 drgbiswas@gmail.com  Dr Rajendra Singh Arora  Sujan Surgicals Cancer Hospital  52/B, Shankar Nagar main Road, Amaravati-444605, Maharashtra, India Amravati   7212671496 dr_rsarora@reddiffmail.com  Dr Rakesh Taran   Taran Onco Care  Ravindra Nagar near Patrakar square Indore 452018 Indore   9009779517 Rakeshtaran@yahoo.com  Dr Nandini Menon  Tata Memorial Centre  Tata Memorial Centre Dr E Borges Marg, Parel - 400012 Mumbai Mumbai   9769178270 nandini.menon1412@gmail.com  Dr V Arumugam  Tirunelveli Medical college and Hospital  "Tirunelveli Govt Medical College And Hospital New Building North High Ground Tirunelveli Tirunelveli Tamil Nadu - 627011 India" Tirunelveli   9842913301 armugamonco@gmail.com  Dr Ankit Patel  Unique Hospital  Civil Hospital-Char Rasta Sosyo Circle, Canal Rd, opp. Kiran Motor, Surat, Gujarat 395002 Surat   9825404202 drankitoncologoist@gmail.com  Dr Amit Jain  Valentis Cancer Care Hospital Pvt. Ltd.  Valentis Cancer Care Hospital Pvt. Ltd. Mussoorie, Mawana Road, Meerut, Uttar Pradesh 250001 Meerut   9410816252 dramit2001@gmail.com  Dr Shashidhar V Karpurmath  Vydehi Institute of Medical Sciences and Research Centre  Vydehi Institute of Medical Sciences and Research Centre #82, EPIP Area, Whitefield, Bengaluru, Karnataka – 560066 Bangalore   8861085629 shashivk5@gmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 49   Name of Committee  Approval Status  All India Institute of Medical Sciences  Approved  Amaravati Ethics Committee SSCHACF  Approved  Dr B L Kapur Memorial Hospital Ethics Committee  Approved  ETHICS COMMITEE FORTIS HOSPITALS LIMITED FARIDABAD  Approved  ETHICS COMMITEE INDO AMERICAN CANCER INSTITUTE AND RESEARCH CENTER  Approved  ETHICS COMMITEE NSCBC RESEARCH INSTITUTE  Approved  Ethics Committee Unique Hospital Multispecialty and Research Institute  Approved  Forties Hospital Institutional Ethics Committee Noida  Approved  HCG Cancer Centre Institutional Ethics Committee- Gulbarga  Approved  HCG- Central Ethics Committee- Bangalore  Approved  IEC DEENANATH MANGESHKAR HOSPITAL AND RESEARCH  Approved  IEC GKMC GOVERMENT KILPAUK MEDICAL COLLEGE AND HOSPITAL   Approved  INISTITUTIONAL ETHICS COMMITTEE TIRUNELVELI  Approved  INSTITUTES ETHICS COMMITEE HCG NMR CANCER CENTER HUBLI  Approved  Institution Ethics Committee CARE Hospital  Approved  Institution Ethics Committee Chandan Hospital  Approved  Institution Ethics Committee HCG Curie City Cancer Centre  Approved  Institution Ethics Committee Krupamayi Hospitals  Approved  Institution Ethics Committee of Forties Hospital Bhandup  Approved  Institution Ethics Committee Sparsh Hospital  Approved  Institutional Ethics Committee AIMS -Kochi  Approved  Institutional Ethics Committee Asian Institute of Medical Science  Approved  Institutional Ethics Committee Erode Cancer Centre  Approved  INSTITUTIONAL ETHICS COMMITTEE KASTURI DAS MEMORIAL HOSPITAL KOLKOTA  Approved  INSTITUTIONAL ETHICS COMMITTEE KGMU  Approved  INSTITUTIONAL ETHICS COMMITTEE LIFE LINE DIAGNOSTICS CENTRE CUM NURSING HOME  Approved  Institutional Ethics Committee Malabar Cancer Centre  Approved  Institutional Ethics Committee Mysore Medical College & Research   Approved  INSTITUTIONAL ETHICS COMMITTEE OMEGA HOSPITALS VISHAKAPATNAM  Approved  Institutional Ethics Committee Oncoville Cancer Hospital and Research Centre  Approved  Institutional Ethics Committee Sai Sneh Hospital and Diagnostic Centre for 7 Orange  Approved  Institutional Ethics Committee Sai Sneh Hospital and Diagnostic Centre for Global Hospital  Approved  INSTITUTIONAL ETHICS COMMITTEE STERLING MULTISPECIALITY HOSPITAL  Approved  Institutional Ethics Committee-1 TATA MEMORIAL HOSPITAL - MUMBAI  Approved  INSTUTIONAL ETHICS COMMITEE NRS MEDICAL COLLEGE AND HOSPITAL  Approved  Kailash Cancer and Medical Centre Institutional Ethics Committee  Approved  KINGS WAY HOSPITALS ETHICS COMMITTEE   Approved  Kiran Hospital Ethics Committee  Approved  KLE Academy of Higher Education and Research Institutional Ethics Committee  Approved  Mahatma Gandhi Cancer Hospital and Research Institute- Institutional Review Board  Approved  Manavata Clinical Research Institution Ethics Committee  Approved  NAVSANJEEVANI HOSPITAL ETHICS COMMITEE  Approved  Poona Medical Research Foundation Institutional Ethics Committee  Approved  RECTITUDE ETHICS COMMITEE INDORE  Approved  SANJEEVANICANCERHOSPITALIEC  Approved  Sapthagiri Institute of Medical Sciences and Research Centre Institutional Ethics Committee  Approved  Tagore Hospital Ethics Committee -Jaipur  Approved  Unity Hospital Ethics Committee  Approved  VYDEHI INSTITUTIONAL ETHICS COMMITTEE  Approved
Regulatory Clearance Status from DCGI	Status  Approved/Obtained
Health Condition / Problems Studied	Health Type  Condition  Patients  Malignant neoplasm of lower respiratory tract, part unspecified
Intervention / Comparator Agent	Type  Name  Details  Intervention  CA-170  Part 1 of the study is dose escalation part where CA-170 shall be administered to the 18-24 subjects along with chemotherapy in open label fashion where, 100 mg BID of the study drug will be administered to first 6 subjects to assess the safety (DLT). 50 mg BID can also be administered to another 6 subjects in parallel to 100 mg BID. If DLT (more than 1 out of 6) is not observed but PK parameters will not be in efficacious range from pre-clinical models then CA-170 dose could be escalated to 200 mg BID Part 2 is double blind randomized part to assess the efficacy of combination of chemotherapy with CA-170 compared with chemotherapy and placebo in terms of PFS.  Comparator Agent  Placebo  In Part 2 of the study which is double blind, efficacy of combination of chemotherapy and CA-170 is compared with combination of chemotherapy and Placebo in terms of PFS
Inclusion Criteria	Age From  18.00 Year(s) Age To  99.00 Year(s) Gender  Both  Details  1. Male and female patients aged 18 years or older. 2. Histologically documented, treatment-naïve Stage IV NonSquamous NSCLC (Version 8 of the International Association for the Study of Lung Cancer (IASLC) Staging Manual in Thoracic Oncology (Appendix E)). 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (Appendix F) 4. Ability to swallow and retain oral medications. 5. Evidence of measurable disease per RECIST, v1.1 as defined as lesion that can be accurately measured in at least 1 dimension with minimum size of 10 mm. 6. Adequate organ and marrow function as defined below: • Absolute neutrophil count (ANC) ≥1.5 x 109/L (1500 per mm3) • Platelets ≥100 x 109/L (100,000 per mm3) • Haemoglobin (Hb) ≥9.0 g/dL (5.59 mmol/L). (Patients can be transfused to bring Hb to this level). • Serum creatinine ≤ 2.0 mg/dL • LFT: ≤ 3 X of ULN for ALT, AST and ≤ 2 X of ULN Total Bilirubin 7. Patients willing and able to provide written informed consent and comply with the requirements of the trial.
ExclusionCriteria	Details  1. Squamous NSCLC histology 2. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody 3. Previous or ongoing treatment (any chemotherapy, therapeutic radiotherapy, or immunotherapy) for Non-Squamous NSCLC Note: Palliative radiotherapy is allowed 4. Participation in another clinical study with an investigational product during the last 3 months 5. Recent major surgery (excluding the placement of vascular access) within 4 weeks (28 days) prior to Day 1 of Cycle 1. (Major surgery is defined as any surgical procedure (other than placement of vascular access device) requiring general anaesthesia) 6. Active or prior documented autoimmune disease requiring the use of systemic immunosuppressive medications (> 10 mg/day of prednisone or equivalent) or other immunomodulator drugs. (Note: Patients with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment are not excluded. In addition, patients with hypothyroidism on thyroid replacement therapy are not excluded) 7. Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, Ulcerative colitis, etc.) 8. History of primary immunodeficiency 9. History of organ transplant that requires therapeutic immunosuppression. 10. Known symptomatic or untreated or recently treated (≤ 6 months of screening) central nervous system (CNS) metastases. Patients with previously treated (> 6 months of screening) CNS metastases who are now stable and asymptomatic are allowed 11. Not eligible for carboplatin and/or pemetrexed, for any reason 12. NSCLC with positive driver mutations, such as Epidermal growth factor receptor (EGFR) mutation or Anaplastic lymphoma kinase (ALK mutation) (Note: Patients who have been tested for driver mutations prior to screening, do not need to be re-tested during screening and available results should be used to determined eligibility per this exclusion criterion 12. Patients not tested for driver mutation prior to screening should be tested during screening). 13. The patient who is expected to require any other form of antineoplastic therapy or targeted therapy while on study. 15. Known history of active tuberculosis within past 5 years. 16. Receipt of live attenuated vaccination within 30 days prior to treatment period day 1 of Cycle 1 17. Current swab-positive or suspected (under investigation) Covid-19 infection or fever and other signs or symptoms suggestive of Covid-19 infection with recent contact of person(s) with confirmed Covid-19 infection, at screening or Day 1 of Cycle 1.18. History of another primary malignancy within 5 years prior to starting study drug, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study. 19. Positive pregnancy test for women of child-bearing potential (WOCBP) at the screening or randomisation visit 20. Lactating women or WOCBP who are neither surgically sterilized nor willing to use reliable contraceptive methods (hormonal contraceptive, IUD, or any double combination of male or female condom, spermicidal gel, diaphragm, sponge, cervical cap)
Method of Generating Random Sequence	Computer generated randomization
Method of Concealment	Other
Blinding/Masking	Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome	Outcome  TimePoints  Part 1: • Safety profile as measured by AEs / SAEs / laboratory parameters graded by NCI CTCAE version 5.0 (Appendix A) • The recommended CA-170 dose to be combined with chemotherapy in Part 2 of the study. Part 2: Progression Free Survival Rates (i.e., Proportion of alive patients without confirmed radiological Progression according to RECIST 1.1 (Appendix B) as determined by an independent central radiologist (ICR) or clinical progression according to the investigator) at 12 months   Part 1: • Safety profile as measured by AEs / SAEs / laboratory parameters graded by NCI CTCAE version 5.0 (Appendix A) • The recommended CA-170 dose to be combined with chemotherapy in Part 2 of the study. Part 2: Progression Free Survival Rates (i.e., Proportion of alive patients without confirmed radiological Progression according to RECIST 1.1 (Appendix B) as determined by an independent central radiologist (ICR) or clinical progression according to the investigator) at 12 months
Secondary Outcome	Outcome  TimePoints  Part 1: • PK profile of CA-170 in combination with chemotherapy • Median PFS Part 2: • Time to progression and ORR by RECIST 1.1 • Overall Survival (OS) • Progression Free Survival (PFS) rates at 6 months, 9 months, 15 months, 18 months, 24 months, and other time points • Median PFS • Time to next treatment • Safety profile as measured by AEs / SAEs / laboratory parameters graded by NCI CTCAE version 5.0• Time to Deterioration of Global Health Status / Health-Related Quality of Life (HRQoL) using European Organization for Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQC-30) • Time to Deterioration of Primary Patient-Reported Outcome (PRO) Symptoms using European Organization for Research and Treatment of Cancer QoL Lung Cancer Module   At 6 months, 9 months, 15 months, 18 months, 24 months, and other time points
Target Sample Size	Total Sample Size="264" Sample Size from India="264"
Phase of Trial	Phase 2/ Phase 3
Date of First Enrollment (India)	22/11/2021
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="5" Months="5" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Open to Recruitment
Publication Details
Brief Summary	Part 1:  • To assess the safety of combination of standard chemotherapy with open label CA-170 • To determine the dose of CA-170 to be combined with standard chemotherapy in Part 2 of the trial. Part 2:  • To assess the efficacy of combination of standard chemotherapy with CA-170 versus standard chemotherapy with placebo, as measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for progression free survival (PFS), in patients with Stage IV non-squamous NSCLC.  Secondary Objectives: a) To assess the PK parameters of CA-170 in combination with chemotherapy (Part 1) b) To assess the efficacy of combination of standard chemotherapy with CA-170 versus standard chemotherapy with placebo as measured by:  • Objective Tumor Response Rate (ORR) • Overall Survival (OS) • Time to Progression (TTP) • Time to next treatment (TNT) c) To assess the safety and tolerability profile of CA-170 in combination with standard chemotherapy d) To assess Patient Reported Outcomes (PRO) and HealthRelated Quality of Life (HRQoL) of study patients treated with combination of standard chemotherapy and CA-170 compared with standard chemotherapy and placebo.   Exploratory Objective: To explore the relationship of efficacy with baseline biomarker assessment, such as PD-L1 and Tumor Mutational Burden (TMB) status.