C6461001_Adults with LA/M NSCLC
Research type
Research Study
Full title
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.
IRAS ID
1013125
Contact name
Helen Joe
Contact email
Sponsor organisation
Pfizer Inc.
Clinicaltrials.gov Identifier
Research 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 locally advanced or metastatic NSCLC.
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.
• Do not be 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 will be assigned to two different parts of the study depending on their type of tumor:
• Part 1: squamous NSCLC
• Part 2: non-squamous NSCLC
Each participant will be randomly assigned 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 with 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 with chemotherapy specific to the type of tumor.
The treatment will be given in cycles, participants will receive PF-08634404 or Pembrolizumab in combination with chemotherapy for the first 4 cycles 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 receive treatment through intravenous (IV) infusions.
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: every 21 days while participant continues receiving treatment, then every 12 weeks thereafter.
• Tests to monitor how cancer responds: every 6 weeks during the first 48 weeks, then every 12 weeks thereafter.REC name
London - Hampstead Research Ethics Committee
REC reference
25/LO/0791
Date of REC Opinion
4 Feb 2026
REC opinion
Unfavourable Opinion