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A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer

NCT04036682 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2025-03-13

No results posted yet for this study

Summary

CLN-081-001 is a Phase 1/2, open label, multi-center study of CLN-081 in patients with non-small cell lung cancer (NSCLC) harboring EGFR (epidermal growth factor receptor) exon 20 insertion mutations, to characterize the safety, determine the recommended Phase 2 dose (RP2D), and evaluate efficacy.

Conditions

  • Non Small Cell Lung Cancer
  • EGFR Exon 20 Mutation

Interventions

DRUG

CLN-081

CLN-081 tablets

Sponsors & Collaborators

  • Cullinan Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Zosia Piotrowska, MD · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-31
Primary Completion
2026-01-31
Completion
2026-03-31
FDA Drug
Yes

Countries

  • United States
  • Hong Kong
  • Italy
  • Japan
  • Netherlands
  • Singapore
  • South Korea
  • Spain
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04036682 on ClinicalTrials.gov