Consider a clinical trial for your patients who have extensive-stage small cell lung cancer in the first-line setting. Connect with a clinical trial site to learn more and see if your patients may be eligible.

The Phase 2/3 clinical trial has two parts:

  • Phase 2 is an open-label, multi-center dose expansion portion of the study to confirm the recommended Phase 3 dose of the study drug (PF-08634404) + chemotherapy
  • Phase 3 is a double-blind, randomized portion of the study to evaluate the efficacy of the study drug (PF-08634404) + chemotherapy versus the comparator drug (atezolizumab) + chemotherapy

Participants may receive the study treatment until objective disease progression per RECIST v1.1 as assessed by investigator (Phase 2) or objective disease progression per blinded independent central review (BICR) (Phase 3). After treatment ends, there will be an in-person follow-up visit, a phone call, or review of medical information every 12 weeks to assess survival status and document anticancer therapies being received.

RECIST, Response Evaluation Criteria in Solid Tumors.

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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 metastatic colorectal cancer and non-small cell lung cancer.1-3

Key eligibility criteria

  • Aged 18 years or older
  • Have histologically or cytologically confirmed ES-SCLC
  • Have not received systemic therapy for ES-SCLC. Note: Participants who received a single cycle of chemotherapy (without immune checkpoint inhibitors) for the management of life-threatening ES-SCLC may be eligible.
  • At least one measurable lesion as the targeted lesion based on RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Additional requirements apply. Only Principal Investigators can determine eligibility.

Study endpoints

TA trials

Primary endpoints-efficacy

  • Confirmed objective response rate per RECIST v1.1 as assessed by investigator (Phase 2)
  • Overall survival (Phase 3)
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Key secondary endpoints (Phase 2)

  • Duration of response by RECIST v1.1 (assessed by investigator)
  • Progression-free survival by RECIST v1.1 (assessed by investigator)
  • Overall survival
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Key secondary endpoint (Phase 3)

  • Progression-free survival by RECIST v1.1 as assessed by BICR
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Safety endpoints (Phase 3)

  • Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), timing, seriousness, and relationship to study intervention
  • Laboratory test abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), and timing
  • Dose-limiting toxicities (Phase 2 only)
about clinical trials

Note: This is not a complete list of study endpoints.

RECIST, Response Evaluation Criteria in Solid Tumors; BICR, blinded independent central review; NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events.

Together, we can make a difference

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.

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References
  1. Xu X, Li W, Liu T, et al. 796P A phase II trial to evaluate the safety and efficacy of SSGJ-707: A bispecific antibody targeting PD-1 and VEGF, in combination with chemotherapy in patients with metastatic CRC. Annals of Oncology. 2025;36. doi: 10.1016/j.annonc.2025.08.1369
  2. 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
  3. 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