Consider a clinical trial for your patients who have squamous and non-squamous NSCLC. Connect with a clinical trial site to learn more and see if your patient may be eligible.
This is a Phase 3, double-blind, randomized clinical trial exploring the efficacy and safety of the study drug (PF-08634404) in combination with chemotherapy versus the comparator drug (pembrolizumab) in combination with chemotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC).
Participants will be randomized 1:1 to one of the following groups:
- Experimental arm: PF-08634404 + chemotherapy
- Control arm: pembrolizumab + chemotherapy
Participants may receive the study treatment for about 2 years or until they or their study doctor decides not to continue the study treatment. After the study treatment ends, participants will have a follow-up visit or phone call every 12 weeks.
About the study medicine
The study medicine, PF-08634404, is a bispecific antibody drug that was designed to target both PD-1 and VEGF. This dual mechanism has the potential to achieve tumor immunosurveillance, while disrupting vascular support for tumor progression, compared with blocking either target alone in patients with solid tumors.
Preliminary clinical data with PF-08634404 as a single agent1 and combined with chemotherapy2 shows encouraging results in patients with first-line NSCLC.
Key eligibility criteria
- Aged 18 years or older
- Have pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLCNot a candidate for surgical resection and curative concurrent/sequential chemoradiotherapy
- Have no known actionable genetic alterations (AGAs) for which there are available first-line therapies per local standard of care
- Have not received previous anti-cancer therapies in the locally advanced or metastatic setting ((neo)adjuvant including anti-PD-(L)1 is allowed)
Additional requirements apply. Only Principal Investigators can determine eligibility.
Study endpoints
Primary endpoint
- Prolonged OS, and prolonged PFS using RECIST v1.1 as assessed by BICR
Key secondary endpoint
- Confirmed ORR using RECIST v1.1 as assessed by BICR
Safety endpoints
- AEs as characterized by type, frequency, intensity as graded by NCI CTCAE v5.0, timing seriousness, and relationship to study intervention(s)
- Laboratory test abnormalities as characterized by type, frequency, severity as graded by NCI CTCAE v5.0, and timing
Note: This is not a complete list of study endpoints.
OS, overall survival; PFS, progression-free survival; ORR, objective response rate; RECIST, Response Evaluation Criteria in Solid Tumors; BICR, blinded independent central review; AE, adverse event; NCI, National Cancer Institute; CTCAE, Common Terminology Criteria for Adverse Events.
People are often introduced to clinical trials through conversations with their healthcare providers. We appreciate you taking the time to have discussions with your patients and their loved ones who may be interested in contributing to research.
Should any of your patients take part in this clinical trial, they will remain under your medical care for all non-study-related needs.
Thank you for considering your patients for this important clinical trial.
1. Wu L, Yao J, Sun Y, et al. A phase II trial to evaluate the safety and efficacy of SSGJ-707, a bispecific antibody targeting PD-1 and VEGF, as a monotherapy in patients with advanced NSCLC. Journal of Clinical Oncology. 2025;43(16_suppl):8543. doi: 10.1200/JCO.2025.43.16_suppl.8543
2. Wu L, Xu H, Sun Y, et al. 1328 SSGJ-707, a PD-1/VEGF bispecific antibody, combined with platinum-based chemotherapy in first-line treatment of advanced non-small cell lung cancer (NSCLC): Results from a phase 2 study. Journal for ImmunoTherapy of Cancer. 2025;13. doi: 10.1136/jitc-2025-SITC2025.1328