Consider a clinical trial for your patients with previously untreated transformed small cell lung cancer. Connect with a clinical trial site to learn more and see if your patients may be eligible.

Symbiotic-Lung-14 is a Phase 2, open-label clinical trial for adults with previously untreated transformed small cell lung cancer (T-SCLC) in the first-line setting. This study is evaluating the safety, tolerability, pharmacokinetics, and antitumor activity of the study medicine, PF-08634404, combined with chemotherapy, followed by monotherapy.

Participants may receive the study treatment until disease progression or until they are no longer deriving clinical benefit as assessed by the Investigator. After the study treatment ends, there will be an in-person end-of-treatment visit, and a follow-up visit or phone call every 12 weeks for assessment of survival and documentation of anticancer treatment.

To view all Symbiotic clinical trials, click here

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 monotherapy 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 T-SCLC
  • Have had a prior diagnosis of NSCLC with EGFR mutation which transformed to SCLC following treatment with TKI(s)
  • Have not received systemic therapy for T-SCLC (participants who received a single cycle of chemotherapy without immune checkpoint inhibitors may be eligible)
  • Have at least 1 measurable lesion per RECIST v1.1
  • Have sufficient tumor tissue from the diagnosis of T-SCLC available (archival tissue or new baseline biopsy with adequate tissue, unless medically infeasible)
  • Have not received anti-angiogenic agents targeting VEGF

Additional requirements apply. Only Principal Investigators can determine eligibility.

Study endpoints

Primary endpoint

  • Confirmed ORR as assessed by Investigator based on RECIST v1.1

Key secondary endpoints

  • DOR as assessed by Investigator based on RECIST v1.1
  • PFS as assessed by Investigator based on RECIST v1.1
  • Overall survival

Safety endpoints

  • AEs as characterized by type, frequency, severity as graded by NCI CTCAE v5.0, timing, seriousness, and relationship to study intervention
  • Laboratory 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.

  •  AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events; DOR, duration of response; NCI, National Cancer Institute; ORR, objective response rate; PFS, progression-free survival.

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. Ann Oncol. 2025;36(suppl 2):S508. 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. J Clin Oncol. 2025;43(suppl 16):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. J Immunother Cancer. 2025;13(suppl 3):A1568-1569. doi:10.1136/jitc-2025-SITC2025.1328