A Novel Investigational
PD-1 x VEGF Bispecific Antibody for NSCLC Patients
This page is intended for healthcare professionals only.
A Novel Investigational
PD-1 x VEGF Bispecific Antibody for NSCLC Patients
This page is intended for healthcare professionals only.
Consider a clinical trial for your patients who have early-stage resectable or locally advanced unresectable squamous or non-squamous NSCLC. Connect with a clinical trial site to learn more and see if your patients may be eligible.
Symbiotic-Lung-10 is a Phase 2, open-label clinical trial evaluating the efficacy and safety of the study medicine (PF-08634404) as monotherapy or in combination regimens in participants with early-stage resectable or locally advanced unresectable non-small cell lung cancer (NSCLC).
There are 3 separate parts based on disease characteristics:
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- Part A (neoadjuvant) receives PF-08634404 + chemotherapy, then surgery
- Part B (adjuvant) receives PF-08634404 alone
- Part C (consolidation) receives PF-08634404 alone
- For Parts B and C, participants may receive the study treatment until the maximum treatment duration is reached or until they or the 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.
Note: For Part A, follow-up is every 12 weeks after End of Treatment visit or recovery from surgery, whichever is later.
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 of the targets 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
All parts
- Aged 18 years or older
- Squamous or non-squamous NSCLC
- Cannot have EGFR and ALK AGAs
- Have sufficient tumor tissue available (archival tissue or new baseline biopsy with adequate tissue, unless medically infeasible)
By part
- Part A: Treatment-naïve, early-stage (Stage II) or locally advanced (Stages IIIA/B) resectable NSCLC
- Part B: Early-stage (Stage II) or locally advanced (Stages IIIA/B) NSCLC
- must have completed neoadjuvant chemo-immunotherapy and surgical resection and not have achieved pCR
- Part C: Locally advanced (Stage III), unresectable NSCLC
- must have no disease progression following concurrent chemoradiotherapy
AGAs, actionable genomic alterations; ALK, anaplastic lymphoma kinase; EGFR, epidermal growth factor receptor; pCR, pathological complete response.
Additional requirements apply. Only Principal Investigators can determine eligibility.
Study endpoints
Primary endpoints
Part A
- Proportion of participants undergoing surgery
- Proportion of participants with wound complications after surgery
- pCR rate per IASLC guidelines as assessed by central pathology review
Parts A, B & C
- AEs as characterized by type, frequency, severity as graded by NCI CTCAE v5.0, timing, seriousness, and relationship to study intervention
Key secondary endpoints
Part A
- MPR rate per IASLC guidelines as assessed by central pathology review and by investigator
- pCR rate per IASLC guidelines as assessed by investigator
- EFS and ORR per RECIST v1.1 as assessed by investigator
- Overall survival
Part B
- DFS per RECIST v1.1 as assessed by investigator
- Overall survival
Part C
- Confirmed ORR and PFS per RECIST v1.1 as assessed by investigator
- Overall survival
Safety endpoint (Parts A, B & C)
- Laboratory abnormalities as characterized by type, frequency, severity as graded by NCI CTCAE v5.0
Note: This is not a complete list of study endpoints.
AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events; DFS, disease-free survival; EFS, event-free survival; IASLC, International Association for the Study of Lung Cancer; MPR, major pathological response; NCI, National Cancer Institute; ORR, objective response rate; PFS, progression-free survival; RECIST, Response Evaluation Criteria in Solid Tumors.
Discover locations for this study
Enter your postcode to see the nearest clinical trial site locations.
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.
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. J Clin Oncol. 2025;43(suppl 16):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. J Immunother Cancer. 2025;13(suppl 3):A1568-A1569. doi:10.1136/jitc-2025-SITC2025.1328
