This study has been transitioned to CTIS with ID 2024-517856-36-00 check the CTIS register for the current data. To assess in comparison to placebo, the impact of adjuvant therapy with MEDI4736 given by intravenous infusion for one year on the…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
Despite evidence of clinical benefit has been observed in non-small cell lung
cancer (NSCLC) patients treated with adjuvant chemotherapy, patients still
relapse and estimated 5-year survival is 50-60%. There is need for new
treatments to improve survival of these patients. MEDI4736 is a PD-L1
inhibitor, inhibition of the PD-1 immune checkpoint pathway has been shown to
induce durable clinical response.
The purpose of this study is to find out whether it is better to receive
MEDI4736, or better to receive no further treatment, after surgery (and
possibly chemotherapy).
Study objective
This study has been transitioned to CTIS with ID 2024-517856-36-00 check the CTIS register for the current data.
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.
Study design
Phase III, multi-centre, prospective, randomized, placebo-controlled trial
Randomization will be 2:1 to the active treatment arm
Stratification by stage, PD-L1 expression,adjuvant platinum based chemotherapy
(yes/no), centre, nodal sampling/dissection conducted in accordance with the
ESTS guidelines (yes/no)
Intervention
MEDI4736 or placebo, via IV infusion in cycles of 4 weeks for one year.
Study burden and risks
On several days during the study patients will undergo the following
assessments:
physical examination
questionnaires (EORTC QLQ C-30-LC13, EQ-5D)
ECG
lung function test
vital signs (blood pressure, pulse)
blood and urine test
CT scan, if applible CT/MRI brain
pregnancy test (if applicable)
echocardiography or MUGA scan (if applicable, once)
Luijbenstraat 15
's-Hertogenbosch 5211BR
NL
Luijbenstraat 15
's-Hertogenbosch 5211BR
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-517856-36-00 |
| EudraCT | EUCTR2014-004946-83-NL |
| ClinicalTrials.gov | NCT02273375 |
| CCMO | NL54852.031.16 |