Who is sponsoring NeoIntercal?

NeoIntercal is sponsored by AIO-Studien-gGmbH.

What condition does NeoIntercal study?

NeoIntercal studies Non-squamous Non-small Cell Lung Cancer Stage II, Non-squamous Non-small Cell Lung Cancer Stage IIIA, Non-squamous Non-small Cell Lung Cancer Stage IIIB, Activating EGFR Mutation, NSCLC.

What drugs are being tested in NeoIntercal?

Interventions: Gefitinib, docetaxel, cisplatin, Surgery.

What is the status of NeoIntercal?

NeoIntercal is currently TERMINATED.

Last reviewed 2018-01-19 · How we verify

Induction Therapy With Gefitinib Followed by Taxane Platinum Chemotherapy and Intercalated Gefitinib in NSCLC Stages II-IIIB With Activating EGFR Mutation - A Single Arm Phase II Trial. (NeoIntercal)

NCT02326285 Phase 2/Phase 3 TERMINATED

This study is designed as a single arm, un-controlled, open-label, multi-center hypothesis generating two-stage phase II trial. It is based on the assumption that the proposed treatment scheme doubles the rate of pathologic complete remission in Mutated epidermal growth factor receptor (EGFRmt) + NSCLC patients compared to historical control data from standard treatments. Patients with NSCLC and activating EGFR mutation in stages II, IIIA and IIIB eligible for induction therapy with docetaxel and cisplatin and gefitinib Patients will be treated for 12 days with gefitinib 250 mg/day p.o. (d -12 to -1) and induced with chemotherapy docetaxel 75 mg/m2 and cisplatin 50 mg/m2 d1+2 and intercalated gefitinib 250 mg/day d4-20 (cycle 1 and 2) and d4-17 (for cycle3). Surgery is planned in the 4th week after d1 of the last cycle.

Details

Lead sponsor	AIO-Studien-gGmbH
Phase	Phase 2/Phase 3
Status	TERMINATED
Enrolment	1
Start date	2015-11
Completion	2018-01

Conditions

Non-squamous Non-small Cell Lung Cancer Stage II
Non-squamous Non-small Cell Lung Cancer Stage IIIA
Non-squamous Non-small Cell Lung Cancer Stage IIIB
Activating EGFR Mutation
NSCLC

Interventions

Gefitinib
docetaxel
cisplatin
Surgery

Primary outcomes

pathologic complete remission rate (pCR rate) — 12 weeks (after 3 cycles and surgery) after enrollment
The primary objective of the study is to assess the pathologic complete remission rate after induction therapy with gefitinib d -12 to d-1 followed by docetaxel 75 mg/m2 and cisplatin 50 mg/m2 d1+2 q21 and intercalated gefitinib 250 mg d4 to d20 (cycle 1 and 2) and d4-17 (for cycle3), in order to demonstrate feasibility and efficacy of this treatment scheme. It is expected to achieve a pCR ≥30% regression grade IIB and III (Junker criteria) compared to historical controls in the mediastinal lymph nodes.

Countries

Germany