A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic NSCLC Patients With Non-squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS

Part of paid clinical trials in Beverly Hills, California.

Sponsor
AstraZeneca
Study ID
NCT06008093
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Participants will receive intravenous (IV) Durvalumab q3w for four 21-day cycles as induction treatment. Durvalumab will also be given during the maintenance treatment period q4w until clinical progression or confirmed RECIST 1.1- defined radiological progression as assessed by the investigator, unacceptable toxicity, withdrawal of participant consent, or EOS, whichever comes first.
  • Tremelimumab — DRUG
    Participants will receive IV Tremelimumab q3w for four 21-days cycles as induction treatment. Tremelimumab will also be given during the maintenance therapy phase at week 16 and week 104 (at the investigators discretion).
  • Pemetrexed — DRUG
    Participants in Arm A and Arm B will receive IV pemetrexed q3w for four 21-day cycles as induction treatment. In the maintenance therapy phase, Treatment Arm A will receive Pemetrexed q4w, Treatment Arm B will receive Pemetrexed q3w until clinical progression or confirmed RECIST 1.1- defined radiological progression as assessed by the investigator, unacceptable toxicity, withdrawal of participant consent, or EOS, whichever comes first.
  • Pembrolizumab — DRUG
    Participants will receive IV pembrolizumab q3w for four 21-days cycles as induction treatment. Pembrolizumab will also be given in the maintenance treatment phase q3w until clinical progression or confirmed RECIST 1.1- defined radiological progression as assessed by the investigator, unacceptable toxicity, withdrawal of participant consent, or EOS, whichever comes first.
  • Carboplatin — DRUG
    Participants will receive IV Carboplatin or IV Cisplatin on Day 1 of each 21-day cycle for 4 cycles as induction treatment.
  • Cisplatin — DRUG
    Participants will receive IV Carboplatin or IV Cisplatin on Day 1 of each 21-day cycle for 4 cycles as induction treatment.

Study Details

The purpose of the study is to assess the efficacy of durvalumab plus tremelimumab in combination with chemotherapy compared with pembrolizumab in combination with chemotherapy in metastatic NSCLC patients with non-squamous histology who have mutations and/or co-mutations in STK11, KEAP1, or KRAS.

Key Dates

Start date
Apr 4, 2024
Status verified
Mar 2026
Primary completion
Dec 8, 2026
Completion
Dec 23, 2027

Study Design

Enrollment
100 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Durvalumab + Tremelimumab + Platinum-based Chemotherapy
    Participants will receive durvalumab plus tremelimumab every 3 weeks (q3w) for four 21-day cycles in combination with chemotherapy followed by maintenance treatment period (durvalumab plus pemetrexed maintenance) every 4 weeks (q4w) until clinical progression or confirmed RECIST 1.1- defined radiological progression as assessed by the investigator, unacceptable toxicity, withdrawal of participant consent, or EOS, whichever comes first. During the maintenance treatment period, participants will receive additional doses of tremelimumab at Cycle 6 (Week 16) and Cycle 28 (Week 104 - at Investigator's discretion) along with durvalumab and pemetrexed.
  • Experimental: Arm B: Pembrolizumab + Platinum-based Chemotherapy
    Participants will receive pembrolizumab regimen q3w for four 21-day cycles in combination with chemotherapy as induction treatment followed by maintenance treatment (pembrolizumab plus pemetrexed maintenance) q3w for up to 24 months, until clinical progression or confirmed RECIST 1.1- defined radiological progression as assessed by the investigator, unacceptable toxicity, withdrawal of participant consent, or EOS, whichever comes first.

Primary Outcome Measure

Progression-free survival (PFS) in randomized participants [ Time Frame: From randomization until death, withdrawal of consent, or the end of the study (approximately 48 months) ]

Locations (47)

FacilityCityStateZIPSite coordinators
Research SiteBeverly HillsCalifornia90211-
Research SiteLa JollaCalifornia92093-
Research SiteLos AlamitosCalifornia90720-
Research SiteLos AngelesCalifornia90034-
Research SiteSanta MonicaCalifornia90404-
Research SiteWashington D.C.District of Columbia20007-
Research SiteFort LauderdaleFlorida33308-
Research SiteJupiterFlorida33458-
Research SiteOcalaFlorida34474-
Research SiteOrlandoFlorida32804-
Research SiteSt. PetersburgFlorida33705-
Research SiteAtlantaGeorgia30318-
Research SiteAtlantaGeorgia30322-
Research SiteHonoluluHawaii96813-
Research SiteCartervilleIllinois62918-
Research SiteUrbanaIllinois61801-
Research SiteBethesdaMaryland20817-
Research SiteJamaica PlainMassachusetts02130-
Research SiteSaint PaulMinnesota55101-
Research SiteKansas CityMissouri64132-
Research SiteSt LouisMissouri63128-
Research SiteBillingsMontana59102-
Research SiteGrand IslandNebraska68803-
Research SiteLincolnNebraska68506-
Research SiteAlbanyNew York12206-
Research SiteEast SyracuseNew York13057-
Research SiteNew YorkNew York10032-
Research SiteShirleyNew York11967-
Research SiteStony BrookNew York11790-
Research SiteSyracuseNew York13210-
Research SiteThe BronxNew York10461-
Research SiteClevelandOhio44111-
Research SiteClevelandOhio44124-
Research SiteClevelandOhio44195-
Research SiteColumbusOhio43210-
Research SiteDaytonOhio45459-
Research SiteNormanOklahoma73072-
Research SitePittsburghPennsylvania15212-
Research SiteSioux FallsSouth Dakota57105-
Research SiteMemphisTennessee38120-
Research SiteDallasTexas75246-
Research SiteDentonTexas76210-
Research SiteHoustonTexas77030-
Research SiteHoustonTexas77090-
Research SiteKingwoodTexas77339-
Research SiteFairfaxVirginia22031-
Research SiteRichmondVirginia23298-

Find similar trials in Beverly Hills, CA

By research site
Research Site· Beverly Hills, CAResearch Site· La Jolla, CAResearch Site· Los Alamitos, CAResearch Site· Los Angeles, CAResearch Site· Santa Monica, CAResearch Site· Washington D.C., DC

Related Studies