A clinical study to check efficacy and safety of Envafolimab injection in treatment of lung cancer.
Scientific Title of Study
A Randomized, Controlled, Double-blind, Multicentre Phase III Clinical Study to Assess Efficacy and Safety of Envafolimab Plus Platinum-based Doublet Chemotherapy Versus Placebo Plus Platinum-based Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy in Subjects with Resectable Stage III Non-Small Cell Lung Cancer.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
GSP 401-302; Version 1.0, Dated: 21-Apr-2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Designation
Affiliation
Address
Phone
Fax
Email
Details of Contact Person Scientific Query
Name
Dr Kanhei Sahoo
Designation
General Manager-Clinical Development
Affiliation
Glenmark Pharmaceuticals Ltd
Address
Glenmark Pharmaceuticals Ltd
Glenmark House, B D Sawant Marg
Chakala, Andheri(East)
Mumbai MAHARASHTRA 400099 India
Phone
912240189999
Fax
Email
Kanhei.Sahoo2@glenmarkpharma.com
Details of Contact Person Public Query
Name
Amol Pendse
Designation
Sr.GM-Clinical Research Operations
Affiliation
Glenmark Pharmaceuticals Ltd.
Address
Glenmark Research Centre, Glenmark Research Centre,
Plot No. A-607, T.T.C. Industrial Area,
MIDC, Mahape, Navi Mumbai Thane MAHARASHTRA 400709 India
Phone
912267720000
Fax
Email
Amol.Pendse@glenmarkpharma.com
Source of Monetary or Material Support
Glenmark Pharmaceuticals Ltd, Glenmark House, B D Sawant Marg
Chakala, Andheri(East) 400099
LMMFs Deenanath Mangeshkar Hospital & Research Center
Erandawane, Pune 411004 Pune MAHARASHTRA
9850811449
drchetandeshmukh@gmail.com
Dr Praveen Shenoy
Malabar Cancer Centre(PGIOSR)
Medical Oncology Ward, Department of Clinical Hematology and Medical Oncology, Ground floor Malabar Cancer Centre, Moozhikkara P.O, Kodiyeri Thalassery Kannur KERALA
9790463281
vppraveen233@gmail.com
Dr Shina Goyal
Max Super Speciality Hopsital
Dwarka (A Unit of Muthoot Hospitals Pvt Ltd), Plot No. 1, Sector 10, Dwarka, New Delhi - 110075 South West DELHI
9773705286
Shina.Goyal@maxhealthcare.com
Dr Ashok Kumar Vaid
Medanta-The Medicity
Sector 38, Gurugram-122001 Gurgaon HARYANA
9810212235
ashok.vaid@medanta.org
Dr Ashish Joshi
MOC Cancer Care & Research Centre
1st Floor, SS House, Nehru Road, Vile Parle, Mumbai 400057 Mumbai MAHARASHTRA
9833662891
ashjoshi44@mocindia.co.in
Dr Narayanankutty Warrier
MVR Cancer Centre and Research Institute
Dept. of Medical Oncology, MVR Cancer Centre and Research Institute, CP 13/516 B.C, Vellalasseri, NIT (Via) , Poolacode, Kozhikode, 673601 Kozhikode KERALA
Khasara No 25, Outer Hingna Ring Road, Mouza Jamtha, Nagpur 441108 Nagpur MAHARASHTRA
9823038498
abpathak21@gmail.com
Dr Pawan Kumar Singh
PGIMS Rohtak
Department of Pulmonory and Critical Care Medicine, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak Rohtak HARYANA
8437013094
ga.ps.complete@gmail.com
Dr Anoop TM
Regional Cancer Centre
Medical College Campus, Medical College P.O, Thiruvananthapuram, Kerala - 695011 Thiruvananthapuram KERALA
9447134973
dranooptm@yahoo.co.in
Dr Tushar Patil
Sahyadri Super Speciality Hospital
Department of Medical Oncology, Plot No. 30 C, Erandawane, Karve Road 411004 Pune MAHARASHTRA
14 Major Arterial Road (E-W), Newtown, Rajarhat, Kolkata 700160 Kolkata WEST BENGAL
9749955500
sayakdey240991@gmail.com
Dr Minit Shah
Tata Memorial Centre
Dr. Ernest Borges Marg, Parel East, Mumbai - 400012 Mumbai MAHARASHTRA
9892640668
minitjshah@gmail.com
Dr Rajan Yadav
The Gujarat Cancer & Research Institute
M.P. Shah Cancer Hospital, Civil Hospital Campus, Asarwa, Ahmedabad -380016 Ahmadabad GUJARAT
8174967504
rajan.yadav@gcriindia.org
Dr Kaushal Kalra
Vardhman Mahavir Medical College and Safdarjung Hospital
Department of Medical Oncology,
Vardhman Mahavir Medical College and Safdarjung Hospital, H693+H6W, NH 48, near AIIMS Hospital, Ansari Nagar West, New Delhi, Delhi 110029 New Delhi DELHI
(1) ICD-10 Condition: C348||Malignant neoplasm of overlappingsites of bronchus and lung,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Envafolimab Injection
Dosage Form: Injection (200 mg [1.0 mL]/vial)
Dose: 600 mg (3 mL)
Dosage Frequency: once in every three weeks
Mode of Administration: Subcutaneous injection.
Comparator Agent
Placebo of Envafolimab Injection
Dosage Form: Injection (1mL/vial)
Dose: 3 mL
Dosage Frequency: once in every three weeks
Mode of Administration: Subcutaneous injection
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Volunteer to participate in the study and sign the informed consent form;
2. Age greater than or equal to 18 years old
3. Histological and/or cytological diagnosis of resectable Stage IIIA-IIIB(N2) NSCLC (IASLC Staging Handbook in Thoracic Oncology/American Joint Committee of Cancer[AJCC], 8th Edition).
4. Measurable lesion(s) based on the RECIST Version 1.1
5. ECOG performance status of 0 to 1
6. Sufficient organ and bone marrow function
7. Expected survival greater than or equal to 6 months
8. The subject meets the criteria for radical surgery and the total lung function is able to withstand the proposed pneumonectomy procedure
9. Female subjects of childbearing potential must undergo a serum pregnancy test within 7 days prior to randomization, with a negative result, and male subjects with a partner of childbearing potential must agree to use a reliable and effective method of contraception during the study as per the study protocol.
ExclusionCriteria
Details
1. Tumour is confirmed as or combined with neuroendocrine carcinoma components (large cell carcinoma, small cell carcinoma, neuroendocrine carcinoma, etc.), or sarcomatous/sarcomatoid lesions, or adenosquamous carcinoma, or special pathological types (such as SMARCA4-deficient type, etc.)
2. Previous treatment with another target T cell receptors (e.g., CTLA-4, OX-40, etc.)
3. Subjects with known EGFR sensitive mutation or ALK translocation
4. Upper lung sulcus tumour or locally advanced unresectable or metastatic disease
5. Subjects who have previously received any anticancer treatment for the study disease (including chemotherapy, radiotherapy, immunotherapy, targeted therapy, etc.); or have received alternative traditional medicine (e.g., ayurveda, homeopathy, Chinese medicine) with anticancer indications within 2 weeks prior to randomization
6. Subjects diagnosed with any other malignancy within 5 years prior to randomization, except for cured localized cancers, including cervical carcinoma in situ, basal cell carcinoma, and low-grade prostate cancer, etc.
7. Subjects who have participated in other clinical studies within 4 weeks prior to randomization.
8. Subjects who have undergone major surgery (excluding diagnostic procedures) within 28 days prior to randomization, or who are expected to undergo non-study major surgery during the study
9. Subjects planned to receive cisplatin who have known or suspected hearing impairment, with consecutive hearing measurements greater than 25 dB.
10. Subjects with greater than or equal to Grade 2 peripheral neuropathy
11. Subjects with known or suspected interstitial pneumonia, radiation pneumonitis or other moderate/severe pulmonary diseases that may interfere with the detection or management of drug-related pulmonary toxicity and severely affect respiratory function
12. Any severe active infection, including active tuberculosis, and bacterial, fungal, or viral infections requiring systemic treatment within 14 days prior to randomization;
13. Active hepatitis B virus infection (HBsAg positive and/or HBcAb positive, with HBV-DNA quantification greater than or equal to 2000 IU/mL) or hepatitis C virus infection (HCV antibody positive and HCV-RNA quantification above the lower limit of detection)
14. Subjects with a known history of HIV infection
15. Subjects with uncontrolled or significant cardiovascular and cerebrovascular disease
16. Subjects who have had active autoimmune disease requiring systemic treatment within 2 years prior to randomization
17. Subjects who have used immunosuppressants or systemic hormone therapy for immunosuppressive purposes within 14 days prior to randomization (prednisone, greater than 10 mg/day or other equivalent hormone therapy)
18. Subjects who have received or are planned to receive a live attenuated vaccine within 28 days prior to randomization or during the study.
19. Subjects with a contraindication or history of hypersensitivity to any component of the study drug (including chemotherapy) or any known excipients
20. Pregnant or breastfeeding women
21. Subjects with other conditions that may interfere with participation in the study or are not expected to benefit from participation, or may affect the study results, such as a history of psychiatric disorders, drug addiction or substance abuse, or any other clinically significant disease or condition.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Major pathologic response (MPR) rate assessed by blinded independent pathology review (BIPR)
Secondary Outcome
Outcome
TimePoints
Pathological complete response (pCR) rate assessed by BIPR
Event Free Survival (FES)
Disease-free survival (DFS)
Overall survival (OS)
Treatment emergent Adverse Events
PK and Immunogenicity (Plasma-drug concentration of envafolimab)
PK and Immunogenicity (ADA and Nab against envafolimab)
Target Sample Size
Total Sample Size="180" Sample Size from India="80" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
30/09/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
30/09/2025
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="3" Months="6" Days="0"
Recruitment Status of Trial (Global)
Open to Recruitment
Recruitment Status of Trial (India)
Open to Recruitment
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This
is a Randomized, Controlled, Double-blind, Multicenter Phase III Clinical Study
to Assess Efficacy and Safety of Envafolimab Plus Platinum-based Doublet
Chemotherapy Versus Placebo Plus Platinum-based Doublet Chemotherapy as
Neoadjuvant/Adjuvant Therapy in Subjects with Resectable Stage III Non-Small
Cell Lung Cancer.
Eligible
subjects who meet all inclusion criteria will be enrolled in the study and
randomized to one of the two treatment groups: Experimental group or Control
Group. The subjects in experimental group will receive Envafolimab along with
platinum-based doublet chemotherapy while the control group subjects will
receive placebo of Envafolimab along with platinum based doubled chemotherapy
during the neoadjuvant period (3-4 cycles, each cycle is 3 weeks). Post-surgery
in the adjuvant setting, the subjects in the experimental group will receive envafolimab
injections, while those in the control arm will receive placebo of Envafolimab
once every 3 weeks, up to 16 cycles. Post last dose, the subject will enter the
follow-up phase which includes safety follow-up, tumor disease follow-up and
survival follow-up. All randomized subjects will undergo survival follow-up
until death, loss to follow-up, or withdrawal of informed consent, whichever
occurs first.
The primary endpoint
of the study is major pathologic response (MPR) rate assessed by blinded
independent pathology review.