A Randomized Phase 2 Platform Study to Evaluate Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for the Perioperative Treatment of Patients with Resectable Non-Small Cell Lung Cancer

Conditions

Non-Small Cell Lung Cancer

Brief summary

Major pathologic response (MPR) rate as determined by central blinded independent pathology review (BIPR)

Detailed description

Pathologic complete response (pCR) rate as determined by central BIPR, Residual viable tumor (RVT) as determined by central BIPR, Median event-free survival (EFS), EFS rate, Objective response rate (ORR), Overall survival (OS), Incidence of treatment-emergent adverse events (TEAEs), Severity of TEAEs, Incidence of TEAEs leading to death, Incidence of TEAEs leading to treatment discontinuation, Incidence of serious adverse events (SAEs), Incidence of adverse events of special interest (AESIs), Incidence of immune-mediated adverse events (imAEs), Incidence of infusion-related reactions (IRRs), Incidence of grade ≥3 laboratory abnormalities, Proportion of delayed surgeries due to TEAEs, Proportion of cancelled surgeries due to TEAEs, Incidence of anti-drug antibodies (ADAs) to cemiplimab over time, Titer of ADAs to cemiplimab over time, Incidence of ADAs to novel anti-cancer agents over time, Titer of ADAs to novel anti-cancer agents over time

Related papers

No related papers found yet.

Interventions

DRUGPemetrexed Fresenius Kabi 500 mg powder for concentrate for solution for infusion

DRUGPaclitaxel AqVida 6 mg/ml concentrate for solution for infusion

DRUGREGN7075

DRUGCisplatinum Accord

DRUG1 mg/ml

DRUGkoncentrat do sporządzania roztworu do infuzji.

DRUGLIBTAYO 350 mg concentrate for solution for infusion.

DRUGCarboplatin Hikma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Major pathologic response (MPR) rate as determined by central blinded independent pathology review (BIPR)	—

Secondary

Measure	Time frame
Pathologic complete response (pCR) rate as determined by central BIPR, Residual viable tumor (RVT) as determined by central BIPR, Median event-free survival (EFS), EFS rate, Objective response rate (ORR), Overall survival (OS), Incidence of treatment-emergent adverse events (TEAEs), Severity of TEAEs, Incidence of TEAEs leading to death, Incidence of TEAEs leading to treatment discontinuation, Incidence of serious adverse events (SAEs), Incidence of adverse events of special interest (AESIs), Incidence of immune-mediated adverse events (imAEs), Incidence of infusion-related reactions (IRRs), Incidence of grade ≥3 laboratory abnormalities, Proportion of delayed surgeries due to TEAEs, Proportion of cancelled surgeries due to TEAEs, Incidence of anti-drug antibodies (ADAs) to cemiplimab over time, Titer of ADAs to cemiplimab over time, Incidence of ADAs to novel anti-cancer agents over time, Titer of ADAs to novel anti-cancer agents over time	—

Measure

Time frame

Pathologic complete response (pCR) rate as determined by central BIPR, Residual viable tumor (RVT) as determined by central BIPR, Median event-free survival (EFS), EFS rate, Objective response rate (ORR), Overall survival (OS), Incidence of treatment-emergent adverse events (TEAEs), Severity of TEAEs, Incidence of TEAEs leading to death, Incidence of TEAEs leading to treatment discontinuation, Incidence of serious adverse events (SAEs), Incidence of adverse events of special interest (AESIs), Incidence of immune-mediated adverse events (imAEs), Incidence of infusion-related reactions (IRRs), Incidence of grade ≥3 laboratory abnormalities, Proportion of delayed surgeries due to TEAEs, Proportion of cancelled surgeries due to TEAEs, Incidence of anti-drug antibodies (ADAs) to cemiplimab over time, Titer of ADAs to cemiplimab over time, Incidence of ADAs to novel anti-cancer agents over time, Titer of ADAs to novel anti-cancer agents over time

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Countries

France, Germany, Spain

Outcome results

None listed