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OncoMatch/Clinical Trials/NCT06933329

Zelenectide Pevedotin in NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer

Is NCT06933329 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Zelenectide pevedotin for non-small cell lung cancer.

Phase 2RecruitingBicycleTx LimitedNCT06933329Data as of May 2026

Treatment: Zelenectide pevedotinThis is a global, multicenter, open-label study that aims to assess the efficacy and safety of zelenectide pevedotin in participants with previously treated NECTIN4-amplified advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior line of systemic therapy in the advanced/metastatic setting (see inclusion criteria below). The study will comprise of 2 cohorts: Cohort A (non-squamous NSCLC) and Cohort B (squamous NSCLC).

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: NECTIN4 amplification

Confirmed NECTIN4 gene amplification by an analytically validated clinical trial assay

Allowed: EGFR actionable genomic alteration

Participants with known actionable genomic alterations (eg, EGFR, ALK, BRAF, MET, ROS1, NTRK1/2/3, RET, etc.) are eligible provided they have received or are not candidates for available standard targeted therapy

Allowed: ALK actionable genomic alteration

Participants with known actionable genomic alterations (eg, EGFR, ALK, BRAF, MET, ROS1, NTRK1/2/3, RET, etc.) are eligible provided they have received or are not candidates for available standard targeted therapy

Allowed: BRAF actionable genomic alteration

Participants with known actionable genomic alterations (eg, EGFR, ALK, BRAF, MET, ROS1, NTRK1/2/3, RET, etc.) are eligible provided they have received or are not candidates for available standard targeted therapy

Allowed: MET actionable genomic alteration

Participants with known actionable genomic alterations (eg, EGFR, ALK, BRAF, MET, ROS1, NTRK1/2/3, RET, etc.) are eligible provided they have received or are not candidates for available standard targeted therapy

Allowed: ROS1 actionable genomic alteration

Participants with known actionable genomic alterations (eg, EGFR, ALK, BRAF, MET, ROS1, NTRK1/2/3, RET, etc.) are eligible provided they have received or are not candidates for available standard targeted therapy

Allowed: NTRK1 actionable genomic alteration

Participants with known actionable genomic alterations (eg, EGFR, ALK, BRAF, MET, ROS1, NTRK1/2/3, RET, etc.) are eligible provided they have received or are not candidates for available standard targeted therapy

Allowed: NTRK2 actionable genomic alteration

Participants with known actionable genomic alterations (eg, EGFR, ALK, BRAF, MET, ROS1, NTRK1/2/3, RET, etc.) are eligible provided they have received or are not candidates for available standard targeted therapy

Allowed: NTRK3 actionable genomic alteration

Participants with known actionable genomic alterations (eg, EGFR, ALK, BRAF, MET, ROS1, NTRK1/2/3, RET, etc.) are eligible provided they have received or are not candidates for available standard targeted therapy

Allowed: RET actionable genomic alteration

Participants with known actionable genomic alterations (eg, EGFR, ALK, BRAF, MET, ROS1, NTRK1/2/3, RET, etc.) are eligible provided they have received or are not candidates for available standard targeted therapy

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 3 prior lines
Min 1 prior line

Must have received: systemic therapy — advanced/metastatic

Participants must have received at least 1 prior line of systemic therapy in the advanced/metastatic setting

Must have received: platinum-based chemotherapy — advanced/metastatic

Participants with no known actionable genomic alterations must have received both platinum based therapy and immunotherapy given either sequentially or in combination for advanced/metastatic NSCLC

Must have received: immunotherapy — advanced/metastatic

Participants with no known actionable genomic alterations must have received both platinum based therapy and immunotherapy given either sequentially or in combination for advanced/metastatic NSCLC

Must have received: targeted therapy — advanced/metastatic

Participants with known actionable genomic alterations...are eligible provided they have received or are not candidates for available standard targeted therapy in the advanced/metastatic setting

Cannot have received: monomethyl auristatin E (MMAE) (vedotin) based therapy

Prior treatment with monomethyl auristatin E (MMAE) (vedotin) based therapy

Cannot have received: systemic anticancer therapy

Prior treatment with any systemic anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to first dose of study treatment

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

US trial sites

  • Alaska Oncology and Hematology, LLC · Anchorage, Alaska
  • University of California, Davis Comprehensive Cancer Center · Sacramento, California
  • Massachusetts General Hospital · Boston, Massachusetts
  • Dana Farber Cancer Institute · Boston, Massachusetts
  • St. Vincent Regional Hospital - Cancer Centers of Montana · Billings, Montana

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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