CTRI/2026/04/108380 [Registered on: 15/04/2026] Trial Registered Prospectively
Last Modified On:
18/06/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Other
Public Title of Study
A Phase 3 Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Advanced Lung Cancer
Scientific Title of Study
An Interventional Phase 3, Double-Blind, Randomized Study to Evaluate Efficacy and Safety of PF-08634404 in Combination With Chemotherapy Versus Pembrolizumab in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NCT07222566
ClinicalTrials.gov
Protocol No. C6461001, PA 2, dated 05-Nov-2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Senior Director Clinical Site Operations – India Cluster
Affiliation
Pfizer Limited
Address
The Capital, 1802/1901,
Plot No. C - 70, G Block, Bandra Kurla Complex, Bandra (East), Mumbai 400 051.
Mumbai MAHARASHTRA 400051 India
Phone
912266932000
Fax
Email
Seema.Pai@pfizer.com
Source of Monetary or Material Support
Pfizer Inc., 66 Hudson Boulevard East, New York, NY 10001, United States
Primary Sponsor
Name
Pfizer Inc.
Address
66 Hudson Boulevard East, New York, NY 10001, United States
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
Pfizer Limited
The Capital, 1802/1901, Plot No. C-70, G Block, Bandra Kurla Complex, Bandra (East), Mumbai 400051, Maharashtra, India
Countries of Recruitment
Argentina Australia Brazil Canada China Czech Republic France Germany Greece Hungary India Israel Italy Japan Poland Republic of Korea Spain Taiwan Turkey United Kingdom United States of America
Sites of Study
No of Sites = 18
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Shailesh Bondarde
Apex Wellness Hospital
Govind nagar, Survey no. 799, Plot no. 187, Behind Prakash petrol Pump, Nashik, Maharashtra, India, 422009 Nashik MAHARASHTRA
9822012427
shaileshbondarde1971@gmail.com
Dr Priya Tiwari
Artemis Hospital
Sector 51, Gurugram, Haryana 122001, India Gurgaon HARYANA
8377828241
priya.tiwari@artemishospitals.com
Dr MVT Krishna Mohan
Basavatarakam Indo American Cancer Hospital & Research Institute (BIACH&RI)
Road No. 10, Banjara Hills, Hyderabad - 500034, Telangana, India Hyderabad TELANGANA
9866154503
mvtkm@yahoo.com
Dr Nirmal Raut
Bhakti Vedanta Hospital and Research Institute
Bhaktivedanta Swami Marg, Mira Road, Bhaktivedanta Hospital & Research Institute, Opposite to ISKCON temple, Thane, Maharashtra, India, 401107 Thane MAHARASHTRA
9930398156
pinirmal123@gmail.com
Dr Unni S Pillai
Caritas Hospital & Institute of Health Sciences
Caritas Cancer Institute, First Floor, Thellakom P O, Kottayam –686630, Kerala, India. Kottayam KERALA
9400061153
unnispillai877@gmail.com
Dr Kalyan Mukherjee
Chittaranjan National Cancer Institute
37, S.P. Mukherjee Road, Kolkata-700026, West Bengal, India. Kolkata WEST BENGAL
9830115905
kkmukherjee4u@hotmail.com
Dr Vineet Gupta
Fortis Hospital
A Block, Shalimar Bagh, New Delhi, Delhi, 110088, India New Delhi DELHI
9911152107
vineet.gupta1@fortishealthcare.com
Dr Santhosh Vandanasetti
Kailash Cancer Hospital and Research Centre
1st Floor, Clinical Research Department, Old Building, Muni Seva Ashram, Goraj, Waghodia, Vadodara-391760, Gujarat, India. Vadodara GUJARAT
9427423693
vandanasetti.santhosh@greenashram.org
Dr Rohan Bhise
KLES Dr. Prabhakar Kore Hospital & M.R.C
NH 4A Nehru Nagar, KLES Dr. Prabhakar Kore Hospital, Nehru nagar Belgaum, Belagavi, Karnataka, India, 590010 Belgaum KARNATAKA
9448866712
rohanbhise30@gmail.com
Dr Gautam Goyal
Max Super Speciality Hospital
OPD No.204, Medical Oncology Department, Basement-2, Near Civil Hospital, Phase-6, Mohali -160055, Punjab, India. Patiala PUNJAB
8195849111
Gautam.Goyal@maxhealthcare.com
Dr Murtaza Bohra
National Cancer Institute
Khasara No. 25, Outer Hingna Ring Road, Mouza, Jamtha, Nagpur - 441108, Maharashtra, India Nagpur MAHARASHTRA
9687657952
dr.murtuza@ncinagpur.in
Dr Anshul Agarwal
Nirmal Hospital Pvt Ltd
Ring Road, Surat, Gujarat, India, 395002 Surat GUJARAT
9377113143
dranshulragarwal@gmail.com
Dr Lokesh
Radhakrishna Multispeciality Hospital & IVF Center
Sector 5, Rohini, New Delhi 110085, Delhi, India. New Delhi DELHI
9873008262
mansisharma08@gmail.com
Dr Tushar Patil
Sahyadri Super Speciality Hospital
30C, Erandwane, Karve Road, Pune, Maharashtra, India, 411004 Pune MAHARASHTRA
9552522556
tushar.patil@sahyadrihospitals.com
Dr Satheesh CT
Spandana Oncology Centre
No. 919, New No. 68, 28th main road, 9th block, Jayanagar, Bangalore 560069, Karnataka, India Bangalore KARNATAKA
9242698750
drsatheeshct@gmail.com
Dr Ghanashyam Biswas
Sparsh Hospitals & Critical Care Pvt Ltd
Department of Medical Oncology, A/407, Room No 2, Annexure Building, Saheed Nagar, Bhubaneswar- 751007, Odisha, India. Khordha ORISSA
9937500878
drgbiswas@sparshhospitals.com
Dr Kumar Prabhash
Tata Memorial Hospital
Room No 204, Homi Bhabha Block, Dr E Borges Road, Parel, Mumbai 400012, Maharashtra, India Mumbai MAHARASHTRA
9167760576
kprabhash1@gmail.com
Details of Ethics Committee
No of Ethics Committees= 18
Name of Committee
Approval Status
Apex Wellness Ethics Committee
Approved
Artemis Health Science institutional Ethics Committee,
Submittted/Under Review
Bhaktivedanta Hospital Ethics Committee
Approved
Ethics Committee – Caritas Hospital, Caritas Hospital & Institute of Health Sciences
Submittted/Under Review
Fortis Hospital Institutional Ethics Committee
Submittted/Under Review
IEC for Spandana Oncology Centre Spandana Oncology Centre
Approved
IEC-Kailash Cancer Hospital and Research Centre
Approved
Institutional Ethics Committee (IEC), Max Super Speciality Hospital
Submittted/Under Review
Institutional Ethics Committee Basavatarakam Indo American Cancer Hospital
Approved
Institutional Ethics Committee Chittaranjan National Cancer Institute
Submittted/Under Review
Institutional Ethics Committee IEC-I
Submittted/Under Review
Institutional Ethics Committee, BGS Global Institute of Medical Sciences
Submittted/Under Review
Institutional Ethics Committee, KLE University
Approved
Institutional Ethics Committee, Sparsh Hospitals & Critical Care Pvt Ltd
Approved
Institutional Review Board
Submittted/Under Review
National Cancer Institute Ethics Committee
Approved
NIRMAL HOSPITAL ETHICS COMMITTEE
Approved
Sahyadri Hospitals Pvt Ltd Ethics Committe
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Pembrolizumab
Dose - 200 mg, Frequency and duration Day 1 of
a 21-day cycle
(Every 3 weeks) - 4 cycles
Intervention
PF-08634404
Dose-10 mg/kg, Frequency and duration-Day 1
of a 21-day cycle
(Every 3 weeks) - 4 cycles
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. 18 years of age or older at screening.
2. Have pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV)squamous or non-squamous NSCLC and not be a candidate for complete surgical resection and curative concurrent or sequential chemoradiotherapy (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer Tumor, lymph nodes, metastasis (TNM) staging system).
3.Have tumor tissue available, either paraffin block or slides from a core, excisional or fine needle biopsy
4. PD-L1 status available based on local testing results
5. Measurable disease based on RECIST v1.1 per investigator.
6. Eastern Cooperative Oncology Group performance status (ECOG) score of 0 or 1
7. Expected survival greater than equal to 12 weeks
ExclusionCriteria
Details
1. Participants with known actionable genomic alteration (AGAs), including estimated glomerular filtration rate (EGFR), anaplastic lymphoma kinase (ALK), Repressor of Silencing 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), v-raf murine sarcoma viral oncogene homolog B1 (BRAF), rearranged during transfection (RET), and mesenchymal-epithelial transition (MET), for which there are available first-line therapies per local standard-of-care (SOC) are ineligible. Documented negative results for EGFR, ALK, and ROS1 AGAs are required for participants with non-squamous histology.
2. Known active CNS lesions are excluded. Participants with definitively treated brain metastases (surgery and or radiotherapy) may be eligible. Clinically inactive brain metastases of longest diameter less than 1 cm are permitted.
3. Participants with clinically significant risk of hemorrhage or fistula are excluded.
4. Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
5. Unresolved toxicities from prior anti-tumor therapy, that did not recover to NCI CTCAE v5.0 Grade 0 or 1.
6. Known to have a history of a severe allergy to any component of the study intervention, or a history of severe allergic reaction to chimeric or humanized antibody.
7. History of allogeneic organ or hematopoietic stem cell transplantation.
8. Participants with any of the following respiratory conditions:
9. Evidence of noninfectious or drug-induced interstitial lung disease (ILD) or pneumonitis
10. Grade greater than equal to 3 pulmonary disease unrelated to underlying malignancy
11. History of uncontrolled comorbidities within 6 months prior to the first dose including uncontrolled cardiac and cerebrovascular conditions, hypertension, diabetes, significant vascular disease or arterial or severe venous thromboembolic events.
12. Major surgery less than 4 weeks or minor surgery less than 3 days prior to first dose of study intervention.
13. History of severe bleeding tendency or coagulation dysfunction
14. History of esophageal varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose.
15. Participants with acute, chronic or symptomatic infections including participants positive for active HIV, hepatitis B virus (HBV), or Hepatitis C virus (HCV).
16. Participants with history of immunodeficiency
17. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior (in the past 5 years) or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.
- Prior systemic therapy, including anti-PD-(L)1 therapy, for locally advanced, unresectable, or metastatic NSCLC.
- Previous treatment with immunotherapy
- Prior radiotherapy greater than 30 Gy to the lung less than 6 months of first dose of study intervention
- Palliative local therapy less than 2 weeks before the first dose of study intervention;
- Non-specific immunomodulatory therapy less than 2 weeks before the first dose.
- Prior systemic anti-angiogenic therapy
19. Prior immune-related AE that led to anti-PD-(L)1 treatment discontinuation, adverse events from prior immunotherapy not improved to Grade 1 before screening, or required treatment with systemic immunosuppressive therapy.
20. Prior and concomitant therapy:
- therapeutic oral or parenteral anticoagulants or thrombolytic agents less than 10 days to the first dose.
- chronic antiplatelet therapy less than7 days to randomization.
- live or attenuated live vaccine less than 4 weeks to the first dose.
- current high-dose systemic corticosteroids.
- prohibited concomitant medication(s) less than 21 days to the first dose.
21. Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.
Method of Generating Random Sequence
Other
Method of Concealment
Other
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
1. Overall Survival
2. Progression Free Survival (PFS) assessed by blinded independent central review (BICR)
Approximately 39 months
Secondary Outcome
Outcome
TimePoints
Confirmed objective response rate (ORR) using RECIST v1.1 as assessed by BICR
Approximately 32 months
Progression Free Survival as assessed by Investigator
Approximately 32 months
Confirmed ORR using RECIST v1.1 as assessed by investigator
Approximately 32 months
Duration of Response (DoR) as assessed by BICR
Approximately 32 months
Duration of Response (DoR) as assessed by Investigator
Approximately 32 months
Number of Participants With Adverse Events (AEs)
Through end of study and up to approximately 39 months
Number of Participants With Clinical Laboratory Abnormalities
through end of study and up to approximately 39 months
Pharmacokinetics (PK): Serum concentrations of PF-08634404
Through end of study and up to approximately 39 months
Incidence of Anti-Drug Antibody (ADA) against PF-08634404
Through end of study and up to approximately 39 months
Mean scores and Change from baseline in the global health status/quality of life (QoL) score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Approximately 39 months
Time to definitive deterioration (TTdD) in in the global health status/QoL score on the EORTC QLQ-C30
Approximately 39 months
Mean scores and Change from Baseline in dyspnea, cough, and chest pain scores on the EORTC Quality of Life Cancer Questionnaire - Lung Cancer 13 QLQ-LC13
Approximately 39 months
TTdD in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13
Approximately 39 months
Target Sample Size
Total Sample Size="1410" Sample Size from India="74" 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)
24/04/2026
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
31/12/2025
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="6" Months="9" Days="0"
Recruitment Status of Trial (Global)
Open to Recruitment
Recruitment Status of Trial (India)
Not Yet Recruiting
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 study is being done to find out if a new medicine called PF-08634404, when given with chemotherapy, works better than the present standard treatment (pembrolizumab with chemotherapy) for adults with a type of lung cancer called non-small cell lung cancer (NSCLC) that is either locally advanced (spread to nearby tissues) or has spread to other parts of the body.
To join the study, participants must meet the following conditions:
Be 18 years or older.
Have locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC.
Is not a candidate for complete surgical resection or curative chemoradiotherapy.
Do not have known actionable genomic alterations
Be treatment naïve for advanced or metastatic disease
Participants in this study will be assigned to two different parts of the study depending on their type of tumor: participants with squamous NSCLC will be assigned to Part 1, while participants with non-squamous NSCLC will be assigned to Part 2.
Each participant will be randomly assigned (like a flip of the coin) to one of two treatment groups in a blinded fashion:
Part 1 - Arm A or Part 2 - Arm C (Experimental Group): Will receive a new study medicine called PF-08634404 along with a kind of chemotherapy specific to the type of tumor.
Part 1 - Arm B or Part 2 - Arm D (Control Group): Will receive an approved medicine called pembrolizumab along with a kind of chemotherapy specific to the type of tumor.
Participants will receive their assigned treatment through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, participants will receive PF-08634404 or Pembrolizumab in combination with chemotherapy followed by maintenance with either PF-08634404 or Pembrolizumab monotherapy (Part 1) or PF-08634404 or Pembrolizumab in combination with a chemotherapeutic drug (Part 2). Participants will continue receiving treatment if it is helping and not experiencing serious side effects.
The study will include regular visits for:
Treatment and health checks: while participant continues receiving treatment.
Tests to monitor how cancer responds: every 6 weeks during the first 48 weeks, then every 12 weeks thereafter.