Osimertinib Plus Capivasertib in NSCLC With PIK3CA/AKT1/PTEN Alterations Following Prior 1L Osimertinib

Sponsor
Shanxi Province Cancer Hospital
Study ID
NCT07486648
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Non-small-cell Lung Cancer
  • Lung Cancer (NSCLC)
  • Lung Cancer (Non-Small Cell)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The goal of this clinical trial is to learn if Osimertinib plus Capivasertib works to treat EGFRm advanced non-small cell lung cancer (NSCLC) in participants with PIK3CA/AKT1/PTEN alterations after progression on first-line Osimertinib (monotherapy or plus chemotherapy). The main questions it aims to answer are: Part A: * Number of Dose-limiting toxicities (DLTs) * Adverse events (AEs)/serious adverse events (SAEs) (graded by CTCAE Version 5.0) * Recommended combined dose (RCD) Part B:Confirmed ORR assessed by the Investigator per RECIST 1.1 criteria. Participants will: Part A:Take Capivasertib twice daily from day 1 to 4 of a 7-day cycle, Osimertinib will be given orally QD(once daily) at 80 mg throughout the study treatment period. Part B: Take Osimertinib (80mg QD, continuously) and Capivasertib(RCD,orally BID from day1-day 4 in 7-day cycle , 4 days on /3 days off) till disease progression (PD) or unacceptable toxicity.

Key Dates

Start date
May 15, 2026
Status verified
Mar 2026
Primary completion
Oct 15, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
53 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Capivasertib 320/400 mg in combination with Osimertinib 80mg
    Capivasertib 320/400 mg (twice daily from day 1 to 4 of a 7-day cycle ),Osimertinib 80 mg( once daily continuously),28 days per cycle

Primary Outcome Measure

Part A Number of Dose-limiting toxicities (DLTs) [ Time Frame: 28 days post first dose of study treatment ]

Central Contacts

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