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Clinical Trials/EUCTR2019-002409-23-NL
EUCTR2019-002409-23-NL
Active, not recruiting
Phase 1

A Phase 1/2, Open-Label, Multi-Center Trial to Assess Safety, Tolerability,Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patientswith Locally-Advanced or Metastatic Non-Small Cell Lung Cancer HarboringEGFR Exon 20 Insertion Mutations who have Previously Received Platinum-Based Systemic Chemotherapy - CLN-081 in exon 20 mutant NSCLC

Cullinan Oncology Inc.0 sites369 target enrollmentOctober 14, 2019
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Conditionson-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion MutationsMedDRA version: 21.1Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
on-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations
Sponsor
Cullinan Oncology Inc.
Enrollment
369
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 14, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Histologically or cytologically confirmed locally advanced or
  • •metastatic NSCLC (all patients). For module A only, histologically or
  • •cytologically confirmed solid tumor with the exception of esophageal,
  • •gastric, pancreatic, hepatobiliary, or small bowel carcinomas, or history of gastric resection.
  • •2\. Documented EGFR exon 20 insertion (ex20ins) mutation
  • •demonstrated by a validated test (per protocol) and performed in a Clinical Laboratory Improvement Amendments (CLIA)\-certified or equivalent laboratory (all patients other than Module A Food Effect PK Assessment Module).
  • •3\. Prior treatment in the recurrent/metastatic disease setting including:
  • •a. A platinum\-based chemotherapy regiment (or other chemotherapy
  • •regimen if platinum\-based chemotherapy is contra\-indicated)
  • •b. Any other approved standard therapy that is available to the patient,

Exclusion Criteria

  • •R6, Phase 1 Expansion, Phase 2a, Module A and Module B Patients Only
  • •1\. Prior treatment with an EGFR ex20ins\-targeting drug (see protocol for
  • •examples). Note: enrolment of patients treated previously with EGFR ex20ins\-targeting drugs allowed selectively during accelerated titration dose escalation and Module C only.
  • •Module A Patients Only
  • •2\. Conditions that compromise esophageal or gastrointestinal (GI)
  • •3\. Recurrent diarrhea, nausea, or vomiting.
  • •4\. Unable to refrain from or anticipates use of any drug, including
  • •prescription and non\-prescription medications (see protocol) for the periods defined in the protocol.
  • •5\. Any allergies to the composition of the high fat meal.
  • •6\. Patients who use tobacco products.

Outcomes

Primary Outcomes

Not specified

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