New Adjuvant Trial of Chemotherapy vs Chemo-immunotherapy

Sponsor
Fundación GECP
Study ID
NCT04564157
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Carboplatin — DRUG
    Structure: The cis-diamino (cyclobutan-1, 1 dicarboxilate) plating. Stability: 24 hours at ambient temperature in 5% glucose, glucosaline or physiologic saline. It is recommended not to dilute with chlorinated solutions for this could affect the carboplatin. Route of administration: Intravenous infusion. Guidelines of Carboplatin administration: According to the standard of each center.
  • Paclitaxel — DRUG
    Structure: A diterpene whose composition is: 5b, 20-epoxy-1, 2a, 4,7b, 10b, 13a-hexa-hidroxytax-11-en 9 one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)- N-benzoyl-3-phenylisoserine. Stability: Concentrations of 0.3-1.2 mg/ml in 5% dextrose or normal saline have demonstrated chemical and physical stability for more that 27 hours at ambient temperature (25ºC approximately). The intact vial must be stored between 15º and 25ºC. Guidelines on Paclitaxel administration: Paclitaxel must be administered by infusion over 3 hours in dextrose (D5W) or normal saline (NS). The concentration must not exceed 1.2 mg/ml.
  • Nivolumab — DRUG
    Structure: Nivolumab is a soluble protein consisting of 4 polypeptide chains. Route of administration: Intravenous infusion. Product Description: Nivolumab (BMS-936558-01) Injection drug product is a sterile, non-pyrogenic, single-use, isotonic aqueous solution formulated in 10 mg/ml. Storage Conditions: It must be stored at 2 to 8 degrees Cº and protected from light and freezing. Guidelines: The administration of nivolumab infusion must be completed within 24 hours of preparation.The dose of Nivolumab for the adjuvant treatment is 360 mg administered as an intravenous infusion over 30 minutes every 3 weeks (+/-3 days) for 4 cycles. For the maintenance adjuvant treatment the dose is nivolumab 480 mg Q4W (+/-3 days) over 30 minutes for 6 months (6 cycles). Subjects should be carefully monitored during nivolumab administration to follow infusion reactions. Doses of nivolumab may be interrupted, delayed, or discontinued depending on how well the subject tolerates the treatment.

Study Details

This is an open-label, randomised, two-arm, phase III, multi-centre clinical trial. 210 stage IB-IIIA, completely resected, non-small cell lung cancer patients will be enrolled in this trial to evaluate the disease free survival between experimental arm (Adjuvant Chemotherapy-Immunotherapy + maintenance adjuvant Immunotherapy) and control arm (Adjuvant Chemotherapy)

Key Dates

Start date
Jan 13, 2021
Status verified
Apr 2026
Primary completion
Apr 1, 2030
Completion
Apr 1, 2031

Study Design

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

Arms

  • Experimental: Adjuvant treatment + Adjuvant maintenance treatment
    Adjuvant treatment: * Paclitaxel: 200mg/m2 infusion over 3 hours * Carboplatin: AUC5 at the end of the Paclitaxel infusion * Nivolumab: 360 mg intravenous Q3W It has to start within 3-10 weeks from surgery and the first administration has to be done within 1-3 days from randomization. 4 cycles will be administered at 21day intervals (QW3) after surgery. A CT-SAN must be done after the 4 cycles of adjuvant treatment. Patients must discontinue treatment if there is evidence of disease relapse. After the 4 cycles of chemo-immunotherapy the patient will receive: Adjuvant maintenance treatment: Nivolumab: 480 mg IV Q4W It will start after 4 weeks from day 1 cycle 4 of adjuvant treatment. 6 cycles will be administered every 28 days. A CT-SAN must be done within +/- 7 days from day 28 of the 3rd cycle of adjuvant maintenance treatment and within +/- 7 days at the end of the 6th cycle. Patients must discontinue treatment if there is evidence of disease relapse at 3rd cycle CT-SCAN.
  • Active Comparator: Control arm: Adjuvant treatment
    Adjuvant treatment: * Paclitaxel: 200mg/m2 infusion over 3 hours * Carboplatin: AUC5 at the end of the Paclitaxel infusion Adjuvant treatment has to start within 3-10 weeks from surgery and the first administration and has to be done within 1-3 days from randomization. 4 cycles will be administered at 21-day (+/- 3 days) intervals (QW3) after surgery. A CT-SAN must be done after the 4 cycles of adjuvant treatment. Observation: 2 observation visits will be done at 3 months and at 6 months from day 21 of cycle 4 of adjuvant treatment.

Primary Outcome Measure

The disease-free survival [ Time Frame: From the date of randomization to the date of last follow up, assessed up to 60 months ]

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