Neo-DIANA: Neoadjuvant Treatment for EGFR Mutated Patients

Sponsor
Fundación GECP
Study ID
NCT04512430
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Patients will receive 1200 mg of Atezolizumab every 21 days (QW3) (+/- 3 days) during neoadjuvant phase and every 28 days (QW4) (+/- 3 days) at adjuvant phase in a monitored setting where there is immediate access to trained personnel and adequate equipment/medicine to manage potentially serious reactions. First Infusion * No premedication administered for atezolizumab specifically is permitted * Infuse atezolizumab (1200 mg in a 250 mL 0.9% NaCl IV bag) over 60 (+/- 15) minutes. Subsequent Infusions: * If patient experienced infusion-related reaction during any previous infusion, premedication with antihistamines may be administered for Cycles \> 2 at the discretion of the treating physician. * If the patient tolerated the first infusion well without infusion-associated adverse events, the successive infusion may be delivered over 30 (+/- 10) minutes.
  • Bevacizumab — DRUG
    Patients will receive 15mg/Kg of Avastin® (bevacizumab) administered by IV infusion every 21 days, for 3 cycles during neoadjuvant phase, in a monitored setting where there is immediate access to trained personnel and adequate equipment/medicine to manage potentially serious reactions.
  • Carboplatin — DRUG
    Structure: The cis-diamino (cyclobutan-1, 1 dicarboxilate) platin. Stability: 24 hours at ambient temperature in 5% glucose, glucosaline or physiologic saline. It is recommended not to dilute with chlorinated solutions since this could affect the carboplatin. Route of administration: Intravenous infusion Patients will receive Carboplatin AUC6 administered by IV infusion every 21 days, for 3 cycles during neoadjuvant phase. Guidelines of Carboplatin administration: According to the standard of each center
  • Pemetrexed — DRUG
    Patients will receive Pemetrexed 500mg/m2 administered by IV infusion every 21 days, for 3 cycles during neoadjuvant phase. Pemetrexed disodium (ALIMTA®, pemetrexed) is a novel pyrrolo\[2,3 d\]pyrimidine-based folic acid analogue. Route of administration: Intravenous infusion. Guidelines of Pemetrexed administration: According to the standard of each center

Study Details

This is an open-label, non-randomised, phase II, multi-centre clinical trial 26 patients will be enrolled in this trial to evaluate the major pathologic response in patients with neoadjuvant treatment with Carboplatin Pemetrexed Bevacizumab plus Atezolizumab in patients with non-small cell lung carcinoma locally advanced mutated in EGFR

Key Dates

Start date
Dec 2, 2020
Status verified
Apr 2025
Primary completion
Jul 19, 2024
Completion
Jul 19, 2024

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Neo-Adjuvant Immunotherapy
    * Neoadjuvant treatment: (Atezolizumab: 1200 mg, IV infusion+Bevacizumab: 15mg/Kg mg, IV infusion+Carboplatin: AUC6, IV infusion+Pemetrexed: 500 mg/m2, IV infusion) will start within 1-3 days from enrollment. 3 cycles will be administered at 21-day (+/- 3 days) intervals (QW3) prior to surgery.Before surgery a tumor assessment will be done. Patients must leave the study if there is evidence of progression. Patients with stable disease or partial response may be considered for surgery. * Surgery: Surgery must be done within the 4th week (+7 days) from day 21 cycle 3 of neoadjuvant treatment (day 42-49 after day 1 of cycle 3). * Adjuvant treatment: Atezolizumab: 1200 mg, IV infusion Q4W (+/- 3 days) for 6 months (6 cycles) Patients that are R0 confirmed by surgical pathology evaluation will receive the first adjuvant administration within the 3rd to 8th week (+7 days) from surgery and for 6 months (6 cycles).

Primary Outcome Measure

Overall Response [ Time Frame: From date of end of neoadjuvant treatment until the date of last follow up, assessed up to 36 months ]

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