An External Control Arm Study in Non-Small Cell Lung Cancer

Conditions

• Non Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Study Details

A study to create control arms using current and future information in patients with lung cancer.

Key Dates

First listed

Sep 15, 2025

Start date

Jan 7, 2026

Status verified

Jun 2026

Primary completion

Apr 30, 2029

Completion

Apr 30, 2029

Study Design

Enrollment

650 participants (estimated)

Arms

• Arm: Cohort 1
  Patients starting first line therapy with ICI single/doublet or ICI in combination with a platinum doublet
• Arm: Cohort 2
  Patients with actionable EGFR mutations starting first line therapy
• Arm: Cohort 3
  Patients with KRAS G12D mutations (excluding KRAS G12C) starting any line of therapy
• Arm: Cohort 4
  Patients with PD-L1 (TPS) greater than or equal to 50% starting second line therapy, after previously being treated with single/doublet ICI or ICI in combination with a platinum doublet as first line treatment.
• Arm: Cohort 5
  Patients with PD-L1 (TPS) \< 50% starting second line therapy, after previously being treated with a platinum doublet in combination with ICI as first line treatment
• Arm: Cohort 6
  Patients without actionable tumor alterations in EGFR, ALK, or ROS 1 where PD-L1 status (TPS) is unknown, starting 2L therapy according to physician's choice
• Arm: Cohort 7
  Patients with KRAS G12C mutation starting second line therapy
• Arm: Cohort 8
  Patients with non-G12 KRAS mutations starting 2L therapy
• Arm: Cohort 9
  Patients with EGFR mutations starting second line or later line of therapy, after previously being treated with osimertinib monotherapy, osimertinib in combination with chemotherapy or lazertinib in combination with amivantamab
• Arm: Cohort 10
  Patients starting 3 line or later line anti-cancer therapy (and not eligible for any other cohort)
• Arm: Cohort 11
  Patients with EGFR exon 19del or EGFR exon 21 L858R locally advanced or metastatic NSCLC diagnosed on Jan 1st, 2025, or later, irrespective of line of therapy or current treatment.

Primary Outcome Measure

Assess Objective Response Rate (ORR) by cohort in patients with metastatic NSCLC treated in second or third line with NCCN recommended therapies [ Time Frame: September 2025-April 2029 ]

Locations (8)

Find similar trials in Monterey, CA

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