NADIM II: Neo-Adjuvant Immunotherapy (NADIMII)
A Randomized Phase II Study of Neo-adjuvant Chemo/Immunotherapy Versus Chemotherapy Alone for the Treatment of Locally Advanced and Potentially Resectable Non-small Cell Lung Cancer (NSCLC) Patients.
Sponsor: Fundación GECP
A observational or N/A phase clinical study on Non Small Cell Lung Cancer, this trial is ongoing. The trial is conducted by Fundación GECP and has accumulated 21 data snapshots since 2019. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)This is an open-label, randomised, two-arm, phase II, multi-centre clinical trial.
Patients randomised to the experimental arm will receive Nivolumab 360mg + Paclitaxel 200mg/m2 + Carboplatin AUC5 for 3 cycles every 21 days as neoadjuvant treatment followed by surgery and 6 months of adjuvant treatment with Nivolumab 480 mg Q4W. Patients randomized to the control arm will receive Paclitaxel 200mg/m2 + Carboplatin AUC5 for 3 cycles every 21 days followed by surgery.
The primary objective is pathological Complete Response (pCR) defined as the absence of residual tumor in lung and lymph nodes comparing patients treated with chemo-immunotherapy versus chemotherapy alone.
Patient accrual is expected to be completed within 3 years excluding a run-in-period of 3 months. Treatment and follow-up are expected to extend the study duration to a total of 8.5 years. Patients will be followed 5 years after adjuvant treatment or surgery. The study will end once survival follow-up has concluded.
This is an open-label, randomised, two-arm, phase II, multi-centre clinical trial.
Patients randomised to the experimental arm will receive Nivolumab 360mg + Paclitaxel 200mg/m2 + Carboplatin AUC5 for 3 cycles every 21 days as neoadjuvant treatment followed by surgery and 6 months of adjuvant treatment with Nivolumab 480 mg Q4W. Patients randomized to the control arm will receive Paclitaxel 200mg/m2 + Carboplatin AUC5 for 3 cycles every 21 days followed by surgery.
The primary objective is pathological Complete Response (pCR) defined as the absence of residual tumor in lung and lymph nodes comparing patients treated with chemo-immunotherapy versus chemotherapy alone.
Patient accrual is expected to be completed within 3 years excluding a run-in-period of 3 months. Treatment and follow-up are expected to extend the study duration to a total of 8.5 years. Patients will be followed 5 years after adjuvant treatment or surgery. The study will end once survival follow-up has concluded.
Status Flow
Change History
21 versions recorded-
May 4, 2026 — Present [daily]
Active Not Recruiting
Phase: PHASE2 → None
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Sep 2025 — May 2026 [monthly]
Active Not Recruiting PHASE2
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May 2025 — Sep 2025 [monthly]
Active Not Recruiting PHASE2
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Feb 2025 — May 2025 [monthly]
Active Not Recruiting PHASE2
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Sep 2024 — Feb 2025 [monthly]
Active Not Recruiting PHASE2
▶ Show 16 earlier versions
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Jul 2024 — Sep 2024 [monthly]
Active Not Recruiting PHASE2
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Feb 2024 — Jul 2024 [monthly]
Active Not Recruiting PHASE2
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Oct 2023 — Feb 2024 [monthly]
Active Not Recruiting PHASE2
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Sep 2022 — Oct 2023 [monthly]
Active Not Recruiting PHASE2
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Jul 2022 — Sep 2022 [monthly]
Active Not Recruiting PHASE2
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Jun 2022 — Jul 2022 [monthly]
Active Not Recruiting PHASE2
Status: Recruiting → Active Not Recruiting
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Dec 2021 — Jun 2022 [monthly]
Recruiting PHASE2
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Sep 2021 — Dec 2021 [monthly]
Recruiting PHASE2
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Jan 2021 — Sep 2021 [monthly]
Recruiting PHASE2
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Jun 2020 — Jan 2021 [monthly]
Recruiting PHASE2
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Feb 2020 — Jun 2020 [monthly]
Recruiting PHASE2
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Dec 2019 — Feb 2020 [monthly]
Recruiting PHASE2
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Oct 2019 — Dec 2019 [monthly]
Recruiting PHASE2
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Jul 2019 — Oct 2019 [monthly]
Recruiting PHASE2
Status: Not Yet Recruiting → Recruiting
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May 2019 — Jul 2019 [monthly]
Not Yet Recruiting PHASE2
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Mar 2019 — May 2019 [monthly]
Not Yet Recruiting PHASE2
First recorded
Eligibility Summary
This is an open-label, randomised, two-arm, phase II, multi-centre clinical trial. 90 patients will be enrolled in this trial to examine the pathological Complete Response defined as the absence of residual tumor in lung and lymph nodes comparing patients treated with chemo-immunotherapy versus chemotherapy alone.
Contact Information
- Fundación GECP
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
A Coruña, Spain , Alicante, Spain , Badalona, Spain , Barakaldo, Spain , Barcelona, Spain , Barcelona, Spain , Barcelona, Spain , Barcelona, Spain , Córdoba, Spain , Girona, Spain and 15 more locations