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A randomized phase II study of neo-adjuvant chemo/immunotherapy versus chemo-therapy alone for the treatment of locally advanced and potentially resectable non-small cell lung cancer (NSCLC) patients_NADIM II

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513731-24-00
Enrollment
90
Registered
2024-06-10
Start date
2019-05-14
Completion date
Unknown
Last updated
2025-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer (NSCLC)

Brief summary

Pathological Complete Response (pCR)

Detailed description

1. Overall survival, 2.Progression-free survival, 3. Major pathological response rate, 4. Downstaging, 5. Portion of delayed/canceled surgeries, length of hospital stays, surgical approach, incidence of AE/SAE related to surgery, 6. Mortality at 90 days after surgery, 7. Safety and tolerability: Adverse events graded according to CTCAE v5.0, 8. Biomarker endpoints, 9. To determine the association between MPR and histology, 10. To determine the association of the histology with the progression free survival at 18 months

Interventions

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

Sponsors

Fundacion GECP
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Pathological Complete Response (pCR)

Secondary

MeasureTime frame
1. Overall survival, 2.Progression-free survival, 3. Major pathological response rate, 4. Downstaging, 5. Portion of delayed/canceled surgeries, length of hospital stays, surgical approach, incidence of AE/SAE related to surgery, 6. Mortality at 90 days after surgery, 7. Safety and tolerability: Adverse events graded according to CTCAE v5.0, 8. Biomarker endpoints, 9. To determine the association between MPR and histology, 10. To determine the association of the histology with the progression free survival at 18 months

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026