Neoplasms

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Carcinoma, Non-Small-Cell Lung

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Bronchial Neoplasms

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Debio 0932 will be administered as daily oral tablets at a starting dose of 250 mg four times per day (QD).

Debio 0932

Cisplatin 75 mg/m2 body surface area (BSA) will be administered on Day 1 of each 21-day treatment cycle.

Pemetrexed 500 mg/m2 BSA will be administered on Day 1 of each 21 day treatment cycle.

Gemcitabine 1250 mg/m2 BSA will be administered on Days 1 and 8 of each 21-day treatment cycle.

Docetaxel 60 or 75 mg/m2 BSA will be administered on Day 1 of each 21-day treatment cycle.

Nicolas Isambert, MD

Jean-Pierre Delord, PR

Jèrôme Fayette, MD

Jaafar Bennouma, MD

Luis Paz-Ares, PR

Enriqueta Felip, PR

Mariano Provencio, PR

Ruth Plummer, PR

Part A of this study will investigate the Maximum Tolerated Dose of Debio 0932 in combination with standard of care chemotherapy for the first- and second-line treatment of advanced NSCLC.

Part A of this study will determine the Maximum Tolerated Dose of Debio 0932 in combination with cisplatin/pemetrexed and cisplatin/gemcitabine in treatment-naïve patients with Stage IIIb or IV NSCLC, and with docetaxel in previously treated patients with Stage IIIb or IV NSCLC.

Escalating doses of Debio 0932 will be given to subsequent patients in combination with standard doses of these 3 background chemotherapies.

A Clinical Study on the Safety and Efficacy of Debio 0932 in Combination With Standard of Care in Patients With Non-small Cell Lung Cancer [NSCLC]

A Phase I-II Evaluation of the Safety and Efficacy of the Oral HSP90 Inhibitor Debio 0932 in Combination With Standard of Care in first-and Second-line Therapy of Patients With Stage IIIb or IV Non-small Cell Lung Cancer-the HALO Study (HSP90 Inhibition And Lung Cancer Outcomes)

Syneos Health

Debiopharm International SA

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Clinical Study on the Safety and Efficacy of Debio 0932 in Combination With Standard of Care in Patients With Non-small Cell Lung Cancer [NSCLC]	NCT01714037	Non-small Cell ...	Debio 0932 Cisplatin Pemetrexed Gemcitabine Docetaxel	18 Years -	Debiopharm International SA
A Clinical Study on the Safety and Efficacy of Debio 0932 in Combination With Standard of Care in Patients With Non-small Cell Lung Cancer [NSCLC]	NCT01714037	Non-small Cell ...	Debio 0932 Cisplatin Pemetrexed Gemcitabine Docetaxel	18 Years -	Debiopharm International SA

Spots Global Cancer Trial Database for standard of care treatment, nsclc