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OncoMatch/Clinical Trials/NCT07227298

Symbiotic-Lung-20: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers

Official title: AN INTERVENTIONAL OPEN-LABEL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF PF-08634404 IN COMBINATION WITH DIFFERENT ANTICANCER AGENTS IN PARTICIPANTS WITH ADVANCED SOLID TUMORS

Is NCT07227298 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies multiple treatments including PF-08634404 and Sigvotatug Vedotin for advanced/metastatic non-small cell lung cancer.

Phase 1/2RecruitingPfizerNCT07227298Data as of Oct 2026Location: International · 9 countries

Treatment: PF-08634404 · Sigvotatug Vedotin · PF-08046054/SGN-PDL1V — This study is being done to learn more about a new medicine called PF-08634404 and how it works when used with other cancer medicines in people who have advanced solid tumors. An advanced solid tumor is a type of cancer that has spread beyond its original location and cannot be removed by surgery or cured with standard treatments. To join in the study, participants must: * Be 18 years or older * Participants with advanced non-small cell lung cancer (NSCLC), a type of lung cancer that has spread to other parts of the body The study will look at: * Whether PF-08634404 is safe to use with other cancer medicines. * What side effects may happen. A side effect is anything the medicine does to your body that is not part of treating your disease. * Whether the combination of PF-08634404 and other cancer medicines can help treat solid tumors. The study has different parts, each testing PF-08634404 with a different cancer medicine: * Part A will test PF-08634404 with a medicine called sigvotatug vedotin. * Part B will test PF-08634404 with a medicine called PF-08046054/SGN-PDL1V Participants will receive the study medicines through an intravenous (IV) infusion (injected into the vein) at the study clinic. All treatments will take place at clinical trial sites, where trained medical staff will monitor participants during and after each visit.

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Extracted eligibility criteria

Treatments studied

Other

PF-08634404Sigvotatug VedotinPF-08046054/SGN-PDL1V

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: PD-L1 (CD274) overexpression (TPS ≥ 1%)

Part B only: PD-L1 ≥ TPS 1%

Excluded: EGFR actionable genomic alteration

Participants with known AGAs including EGFR, ALK and ROS1, NTRK, BRAF, and MET for which there are available first-line therapies per local standard-of-care (SOC)

Excluded: ALK actionable genomic alteration

Participants with known AGAs including EGFR, ALK and ROS1, NTRK, BRAF, and MET for which there are available first-line therapies per local standard-of-care (SOC)

Excluded: ROS1 actionable genomic alteration

Participants with known AGAs including EGFR, ALK and ROS1, NTRK, BRAF, and MET for which there are available first-line therapies per local standard-of-care (SOC)

Excluded: NTRK1 actionable genomic alteration

Participants with known AGAs including EGFR, ALK and ROS1, NTRK, BRAF, and MET for which there are available first-line therapies per local standard-of-care (SOC)

Excluded: NTRK2 actionable genomic alteration

Participants with known AGAs including EGFR, ALK and ROS1, NTRK, BRAF, and MET for which there are available first-line therapies per local standard-of-care (SOC)

Excluded: NTRK3 actionable genomic alteration

Participants with known AGAs including EGFR, ALK and ROS1, NTRK, BRAF, and MET for which there are available first-line therapies per local standard-of-care (SOC)

Excluded: BRAF actionable genomic alteration

Participants with known AGAs including EGFR, ALK and ROS1, NTRK, BRAF, and MET for which there are available first-line therapies per local standard-of-care (SOC)

Excluded: MET actionable genomic alteration

Participants with known AGAs including EGFR, ALK and ROS1, NTRK, BRAF, and MET for which there are available first-line therapies per local standard-of-care (SOC)

Disease stage

Required: Stage IIIB, IIIC, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 0 prior lines

Cannot have received: systemic anti-tumor therapy for locally advanced or metastatic NSCLC

Previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC

Cannot have received: immunotherapy

Exception: (neo)adjuvant or consolidation anti-PD-(L)1 permitted

Previous treatment with immunotherapy (exception is (neo)adjuvant or consolidation anti-PD-(L)1)

Cannot have received: antibody-drug conjugate containing MMAE payload

ADCs containing MMAE payload

Cannot have received: systemic anti-angiogenic therapy

systemic anti-angiogenic therapy

Lab requirements

Blood counts

Kidney function

Liver function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Highlands Oncology Group, PA · Fayetteville, Arkansas
  • Highlands Oncology Group, PA · Rogers, Arkansas
  • Highlands Oncology Group, PA · Springdale, Arkansas
  • Providence Medical Foundation · Fullerton, California
  • Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center and Infusion Center · Fullerton, California

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT07227298 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC, immunotherapy, antibody-drug conjugate containing MMAE payload disqualifies patients from enrollment.

Does this trial require CD274?

Yes, CD274 overexpression is a required biomarker for enrollment.

Are patients with EGFR alterations eligible?

No. EGFR actionable genomic alteration is an exclusion criterion.

Are patients with ALK alterations eligible?

No. ALK actionable genomic alteration is an exclusion criterion.

What disease stage is eligible?

Stage IIIB or IIIC or IV is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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