Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC

Conditions

• EGFR-mutant Non-small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• EGF816 — DRUG
  Study Drug
• trametinib — DRUG
  Study Drug
• ribociclib — DRUG
  Study Drug
• LXH254 — DRUG
  Study Drug
• INC280 — DRUG
  Study Drug
• gefitinib — DRUG
  Study Drug

Study Details

The study purpose is to evaluate the safety, tolerability, and preliminary efficacy of the addition of INC280, trametinib, ribociclib, gefitinib, or LXH254 to EGF816 in adult patients with advanced Epidermal growth factor receptor- mutant (EGFR-mutant) non-small cell lung cancer (NSCLC).

Key Dates

Start date

Jan 29, 2018

Status verified

Jan 2026

Primary completion

Oct 5, 2026

Completion

Oct 5, 2026

Study Design

Enrollment

105 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1
  EGF816+ trametinib in escalation phase
• Experimental: Arm 2
  EGF816 + ribociclib in escalation phase
• Experimental: Arm 3
  EGF816 + LXH254 in escalation phase
• Experimental: Arm A
  EGF816 + INC280 in expansion phase (patients with no known resistance mechanism)
• Experimental: Arm B
  EGF816 + trametinib in expansion phase
• Experimental: Arm C
  EGF816 + ribociclib in expansion phase
• Experimental: Arm D
  EGF816 + LXH254 in expansion phase (patients with no known resistance mechanism)
• Experimental: Arm E
  EGF816 + LXH254 in expansion phase (patients with known resistance mechanism)
• Experimental: Arm F
  EGF816 + gefitinib in expansion phase
• Experimental: Arm G
  EGF816 + INC280 in expansion phase (patients with known resistance mechanism)

Primary Outcome Measure

Number of patients with adverse events and serious adverse events [ Time Frame: Every day until study end, approximately 4 years ]