Clinical Trial: NCT03838159
NADIM II: Neo-Adjuvant Immunotherapy
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 2| Lead Sponsor: | Fundación GECP |
| Information Provided By: | Fundación GECP |
| Last Update Posted: | 2026-04-30 |
Study Overview
Brief 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.
Official Title
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.
Conditions
Non Small Cell Lung Cancer
Intervention / Treatment
- Drug: Paclitaxel
- Drug: Carboplatin
- Drug: Nivolumab
Other Study ID Numbers
- GECP 18/02_NADIM II
- 2018-004515-45
- 2018
Start Date (Actual)
2019-05-15
Primary Completion Date (Estimated)
2027-11-30
Study Completion Date (Estimated)
2028-11-30
Enrollment (Actual)
90
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | Fundación GECP |
| Information Provided By: | Fundación GECP |
| Last Update Posted: | 2026-04-30 |
Study Overview
Brief 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.
Official Title
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.
Conditions
Non Small Cell Lung Cancer
Intervention / Treatment
- Drug: Paclitaxel
- Drug: Carboplatin
- Drug: Nivolumab
Other Study ID Numbers
- GECP 18/02_NADIM II
- 2018-004515-45
- 2018
Start Date (Actual)
2019-05-15
Primary Completion Date (Estimated)
2027-11-30
Study Completion Date (Estimated)
2028-11-30
Enrollment (Actual)
90
Study Type
Interventional
Phase
Phase 2