๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-06-15

A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer (NCT04036682)

A Phase 1/2, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients With Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Previously Received Platinum-Based Systemic Chemotherapy

๐Ÿ”ต Active, Not Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Cullinan Therapeutics Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Pacific Cancer Medical Center, Inc โ€” Anaheim, California

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (64 Sites)

Showing the first 25 of 64 sites.

  • Pacific Cancer Medical Center, Inc โ€” Anaheim, California
  • City of Hope Comprehensive Cancer Center โ€” Duarte, California
  • City of Hope at Irvine Lennar โ€” Irvine, California
  • Pacific Shores Medical Group โ€” Long Beach, California
  • AdventHealth โ€” Orlando, Florida
  • Massachusetts General Hospital โ€” Boston, Massachusetts
  • University of Michigan Health System - University Hospital โ€” Ann Arbor, Michigan
  • Summit Medical Group PA โ€” Florham Park, New Jersey
  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island โ€” Mineola, New York
  • New York University Langone Health โ€” New York, New York
  • Columbia University Irving Medical Center โ€” New York, New York
  • Memorial Sloan Kettering Cancer Center โ€” New York, New York
  • Gabrail Cancer Center Research โ€” Canton, Ohio
  • Providence Cancer Center โ€” Portland, Oregon
  • Providence Oncology & Hematology Care Clinic-Westside โ€” Portland, Oregon
  • UPMC Hillman Cancer Center โ€” Pittsburgh, Pennsylvania
  • Medical University of South Carolina โ€” Charleston, South Carolina
  • Virginia Cancer Specialists โ€” Fairfax, Virginia
  • Hong Kong University - Queen Mary Hospital โ€” Hong Kong,
  • Azienda Ospedaliero Universitaria Careggi โ€” Careggi,
  • Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I โ€” Marche,
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS โ€” Meldola,
  • IRCCS-Istituto Europeo di Oncologia โ€” Milan,
  • Azienda Ospedaliero Universitaria Modena โ€” Modena,
  • San Gerardo Hospital โ€” Monza,

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—