A Biomarker-Directed Phase 2 Platform Study in Patients with Advanced Non-Small Cell Lung Cancer whose Disease has Progressed on First-Line Osimertinib Therapy (ORCHARD)

Conditions

Advanced Non-Small Cell Lung Cancer

Brief summary

To assess the efficacy of each treatment by evaluation of objective response rate - Endpoint based on Response Evaluation Criteria in Solid Tumours (RECIST 1.1) • Objective response rate (ORR)

Detailed description

To assess the efficacy of each treatment by evaluation of tumour response and overall survival Overall survival (OS) - Endpoint based on Response Evaluation Criteria in Solid Tumours (RECIST 1.1): • Progression-free survival (PFS) • Duration of response (DoR), To assess the pharmacokinetics (PK) of each treatment: plasma/serum concentrations will be measured., To assess the safety and tolerability of each treatment - • Adverse events/serious adverse events (AEs/SAEs): • Physical examinations • Laboratory findings • Vital signs • Electrocardiogram (ECG). • Left ventricular ejection fraction (LVEF)

Related papers

No related papers found yet.

Interventions

DRUGCARBOPLATIN

DRUGDatopotamab deruxtecan

DRUGInflectra 100 mg powder for concentrate for solution for infusion

DRUGETOPOSIDE

DRUGCISPLATIN

DRUGMycophenolate Mofetil Accord 250 mg capsules

DRUGTAGRISSO 80 mg film-coated tablets

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

DRUGTAGRISSO 40 mg film-coated tablets

DRUGKoselugo 25 mg hard capsules

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To assess the efficacy of each treatment by evaluation of objective response rate - Endpoint based on Response Evaluation Criteria in Solid Tumours (RECIST 1.1) • Objective response rate (ORR)	—

Secondary

Measure	Time frame
To assess the efficacy of each treatment by evaluation of tumour response and overall survival Overall survival (OS) - Endpoint based on Response Evaluation Criteria in Solid Tumours (RECIST 1.1): • Progression-free survival (PFS) • Duration of response (DoR), To assess the pharmacokinetics (PK) of each treatment: plasma/serum concentrations will be measured., To assess the safety and tolerability of each treatment - • Adverse events/serious adverse events (AEs/SAEs): • Physical examinations • Laboratory findings • Vital signs • Electrocardiogram (ECG). • Left ventricular ejection fraction (LVEF)	—

Measure

Time frame

To assess the efficacy of each treatment by evaluation of tumour response and overall survival Overall survival (OS) - Endpoint based on Response Evaluation Criteria in Solid Tumours (RECIST 1.1): • Progression-free survival (PFS) • Duration of response (DoR), To assess the pharmacokinetics (PK) of each treatment: plasma/serum concentrations will be measured., To assess the safety and tolerability of each treatment - • Adverse events/serious adverse events (AEs/SAEs): • Physical examinations • Laboratory findings • Vital signs • Electrocardiogram (ECG). • Left ventricular ejection fraction (LVEF)

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Countries

Italy, Netherlands, Norway, Spain, Sweden

Outcome results

None listed