A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer.

Recruiting Phase 3 Interventional Study
Non Small Cell Lung Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
290 (estimated)
Sponsor
ETOP IBCSG Partners Foundation · Research network
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About This Trial
ADOPT-lung is an international, multicentre, open-label randomised phase III trial. Protocol treatment consists of 3-4 cycles of neoadjuvant durvalumab in combination with platinum-based doublet chemotherapy, followed by surgery. Patients with R0 and R1 only resection will be randomised to receive either adjuvant durvalumab for 12 cycles (experimental arm) or observation (control arm). The primary…
Trial Locations
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Eligibility Criteria
Inclusion Criteria for enrolment: * Histologically confirmed NSCLC. * Stage IIB-IIIB (T1-4 N0-2) according to 8th edition of the TNM staging system of lung cancer. Stage III assessment should include samples of lymph nodes at levels 4, bilaterally, and level 7 to rule out stage IIIB N3 disease. T…
Contacts

Heidi Roschitzki, PhD

+41 31 511 94 00

heidi.roschitzki@etop.ibcsg.org

CONTACT

Susanne Roux

+41 31 511 94 00

ADOPT-lung@etop.ibcsg.org

CONTACT