A phase III prospective double blind placebo controlled randomized study of adjuvant MEDI4736 in completely resected non-small cell lung cancer

A phase III prospective double blind placebo controlled randomized study of adjuvant MEDI4736 in completely resected non-small cell lung cancer - NVALT 24

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54539

Enrollment

Registered

2016-03-29

Start date

2017-04-26

Completion date

Unknown

Last updated

2025-01-13

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

Conditions

lung cancer lung carcinoma

Interventions

MEDI4736 or placebo, via IV infusion in cycles of 4 weeks for one year.

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Histologically confirmed NSCLC (post-operatively stage IB, II or IIIA) Complete surgical resection ECOG PS 0-1 Adequate bone marrow, hepatic and renal function Age 18 years or older After 600 randomizations, only PD-L1 positive patients will be enrolled

Exclusion criteria

Exclusion criteria: combination of small cell and non-small cell lung cancer or pulmonary carcinoid tumour autoimmune disease untreated and/or uncontrolled cardiovascular conditions and/or symptomatic cardiac dysfunction Pregnant or lactating women Pre-operative chemotherapy pre- or post operative RT

Design outcomes

Primary

Measure	Time frame
To assess in comparison to placebo, the impact of adjuvant therapy with MEDI4736 given by intravenous infusion for one year on the disease free survival of patients with completely resected (stage IB > 4cm, stage II or IIIA), non-small cell lung cancer that is PD-L1 positive.	—

Secondary

Measure	Time frame
Disease free survival in all randomized patients. To compare the overall survival in the MEDI4736 arm to the placebo arm in patients with NSCLC that is PD-L1 positive. To compare the overall survival in the MEDI4736 arm to the placebo arm in all randomized patients. To compare lung cancer specific survival in the MEDI4736 arm to the placebo arm for patients with PD-L1+ NSCLC as well as all randomized patients. • To evaluate the nature, severity, and frequency of toxicities, between arms. • To evaluate the quality of life between the two arms in PD-L1+ patients and in all randomized patients. • To determine the incremental cost effectiveness and cost utility ratios for MEDI4736. • To evaluate the prognostic and predictive significance of PD-L1 expression. • To evaluate changes in plasma/serum cytokines and other blood and tissue based biomarkers after treatment with MEDI4736 and at the first disease event (relapse or new invasive primary malignancy). • To explore polymorphisms that may be associated with outcomes	—

Measure

Time frame

Disease free survival in all randomized patients. To compare the overall survival in the MEDI4736 arm to the placebo arm in patients with NSCLC that is PD-L1 positive. To compare the overall survival in the MEDI4736 arm to the placebo arm in all randomized patients. To compare lung cancer specific survival in the MEDI4736 arm to the placebo arm for patients with PD-L1+ NSCLC as well as all randomized patients. • To evaluate the nature, severity, and frequency of toxicities, between arms. • To evaluate the quality of life between the two arms in PD-L1+ patients and in all randomized patients. • To determine the incremental cost effectiveness and cost utility ratios for MEDI4736. • To evaluate the prognostic and predictive significance of PD-L1 expression. • To evaluate changes in plasma/serum cytokines and other blood and tissue based biomarkers after treatment with MEDI4736 and at the first disease event (relapse or new invasive primary malignancy). • To explore polymorphisms that may be associated with outcomes

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)