Nivolumab plus Ipilimumab plus two cycles of platinum-based chemotherapy as first line treatment for stage IV/recurrent non-small cell lung cancer (NSCLC) patients with synchronous Brain metastases_NIVIPI-Brain

Conditions

Non-small cell lung cancer with brain metastasis

Brief summary

The primary objective of this trial is to determine the rate of intracranial clinical benefit, defined as the percentage of patients who had lack of radiological or clinical progression for at least 6 months according to RANO-BM assessment criteria.

Detailed description

1. To evaluate the efficacy of Nivolumab + Ipilimumab + 2 cycles of chemotherapy in patients with NSCLC and synchronous brain metastases in terms of objective response rate (ORR), duration of response (DOR), progression-free survival (PFS) and overall survival (OS)., 2, To evaluate the efficacy of Nivolumab + Ipilimumab + 2 cycles of chemotherapy in patients with NSCLC and synchronous brain metastases in terms of the investigator assessed bicompartimental PFS defined as systemic PFS (excluding CNS) as per RECIST version 1.1 and PFS in the CNS as per RANO-BM criteria, 3, To evaluate the safety of Nivolumab + Ipilimumab + 2 cycles of chemotherapy in patients with NSCLC and synchronous brain metastases., 4, Overall survival (OS) at 12, 18 and 24 defined as the time from enrollment to death from any cause at this landmark timepoints, 5, To determine the quality of life (QoL)

Related papers

No related papers found yet.

Interventions

DRUGYERVOY 5 mg/ml concentrate for solution for infusion

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary objective of this trial is to determine the rate of intracranial clinical benefit, defined as the percentage of patients who had lack of radiological or clinical progression for at least 6 months according to RANO-BM assessment criteria.	—

Secondary

Measure	Time frame
1. To evaluate the efficacy of Nivolumab + Ipilimumab + 2 cycles of chemotherapy in patients with NSCLC and synchronous brain metastases in terms of objective response rate (ORR), duration of response (DOR), progression-free survival (PFS) and overall survival (OS)., 2, To evaluate the efficacy of Nivolumab + Ipilimumab + 2 cycles of chemotherapy in patients with NSCLC and synchronous brain metastases in terms of the investigator assessed bicompartimental PFS defined as systemic PFS (excluding CNS) as per RECIST version 1.1 and PFS in the CNS as per RANO-BM criteria, 3, To evaluate the safety of Nivolumab + Ipilimumab + 2 cycles of chemotherapy in patients with NSCLC and synchronous brain metastases., 4, Overall survival (OS) at 12, 18 and 24 defined as the time from enrollment to death from any cause at this landmark timepoints, 5, To determine the quality of life (QoL)	—

Measure

Time frame

1. To evaluate the efficacy of Nivolumab + Ipilimumab + 2 cycles of chemotherapy in patients with NSCLC and synchronous brain metastases in terms of objective response rate (ORR), duration of response (DOR), progression-free survival (PFS) and overall survival (OS)., 2, To evaluate the efficacy of Nivolumab + Ipilimumab + 2 cycles of chemotherapy in patients with NSCLC and synchronous brain metastases in terms of the investigator assessed bicompartimental PFS defined as systemic PFS (excluding CNS) as per RECIST version 1.1 and PFS in the CNS as per RANO-BM criteria, 3, To evaluate the safety of Nivolumab + Ipilimumab + 2 cycles of chemotherapy in patients with NSCLC and synchronous brain metastases., 4, Overall survival (OS) at 12, 18 and 24 defined as the time from enrollment to death from any cause at this landmark timepoints, 5, To determine the quality of life (QoL)

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Countries

Spain

Outcome results

None listed