Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT06731413
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Reduced Dose of Chemotherapy and Immunotherapy — DRUG
    Eligible participants with recurrent or metastatic squamous cell carcinoma will receive 4 cycles of carboplatin area under the curve (AUC) 3 IV every 21 days and paclitaxel 135 mg/m2 intravenous (IV) every 21 days. Participants with non-squamous histology will receive carboplatin AUC 3 IV every 21 days and pemetrexed 375 mg/m2 IV every 21 days (collectively, induction chemotherapy). Both groups will receive pembrolizumab 200 mg IV every 21 days for a total of up to 35 cycles (Cycles ≥5 are collectively the maintenance portion of treatment) or until disease progression or unacceptable toxicity.

Study Details

Evaluate frequency of adverse events that lead to chemotherapy discontinuation in vulnerable older adults with recurrent/metastatic PD-L1 TPS\<50% NSCLC patients who receive reduced dose chemotherapy in combination with immunotherapy.

Key Dates

Start date
Feb 11, 2025
Status verified
May 2026
Primary completion
Jul 30, 2030
Completion
Jul 30, 2033

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Reduced Dose Combination Therapy
    Squamous cell histology: 1. Carboplatin AUC 3 every 21 days IV for 4 cycles 2. Paclitaxel 135 mg/m2 every 21 IV days for 4 cycles 3. Pembrolizumab 200 mg every 21 days IV until disease progression or unacceptable toxicity up to 35 cycles Non-squamous histology: 1. Carboplatin AUC 3 every 21 days IV for 4 cycles 2. Pemetrexed 375 mg/m2 every 21 IV days for 4 cycles 3. Pembrolizumab 200 mg every 21 days IV until disease progression or unacceptable toxicity up to 35 cycles

Primary Outcome Measure

Occurrence of chemotherapy discontinuation due to treatment-related adverse events [ Time Frame: Through completion of protocol therapy, up to 2 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth UniversityRichmondVirginia23298
Massey Lung Team
[email protected]
804-628-6430
Jonathan Berkman, MD (PRINCIPAL_INVESTIGATOR)
VCU Health Tappahannock HospitalTappahannockVirginia22560
Massey CTO Lung Team
[email protected]
804-628-6430
Jonathan Berkman, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Richmond, VA

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By research site
Virginia Commonwealth University· Richmond, VAVCU Health Tappahannock Hospital· Tappahannock, VA

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