Consider a clinical trial for your patients who have squamous or non-squamous NSCLC. Connect with a clinical trial site to learn more and see if your patients may be eligible.
This is a Phase 1b/2, open-label clinical trial exploring the safety, pharmacokinetics, and preliminary efficacy of the study drug, PF-08634404, in combination with different anticancer agents in participants with locally advanced or metastatic (LA/M) NSCLC.
Participants will be assigned to one of the following groups:
- Part A: study drug PF-08634404 + a second study drug sigvotatug vedotin (SV)
- Part B: study drug PF-08634404 + a second study drug
Participants may receive the study treatment until the study ends, or the participant 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 agent and combined with chemotherapy shows encouraging results in patients with first-line NSCLC.1,2
Key eligibility criteria
- Aged 18 years or older
- Have pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC
- Not 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 anticancer therapies in the locally advanced or metastatic setting or prior immunotherapy treatment
- ((neo)adjuvant anti-PD-(L)1 is allowed if recurrence or progression occurred ≥9 months after the last dose)
Additional requirements apply. Only Principal Investigators can determine eligibility.
Study endpoints
Primary endpoints
- AEs as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), timing, seriousness, and relationship to study intervention
- Phase 1b: Dose-limiting toxicities
- Phase 2: Confirmed ORR per RECIST v1.1 by investigator
Key secondary endpoints
- Phase 1b: Confirmed ORR per RECIST v1.1 by investigator
- DCR, DOR, and PFS per RECIST v1.1 by investigator
- Overall survival (OS)
- Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), and timing
- Predose and/or postdose concentrations of PF-08634404, SV, and a second study drug
- Incidence of ADA against PF-08634404, SV, and a second study drug
Note: This is not a complete list of study endpoints.
ADA, anti-drug antibody; AEs, adverse events; DCR, disease control rate; DOR, duration of response; NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; ORR, objective response rate; PFS, progression-free survival; RECIST, Response Evaluation Criteria in Solid Tumors; SV, sigvotatug vedotin.
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.
References
- 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
- 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.