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] (HALO)

Debiopharm

Status and phase: Terminated; Phase 1

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Gemcitabine; Drug: Debio 0932; Drug: Cisplatin; Drug: Pemetrexed; Drug: Docetaxel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01714037

Debio 0932-201

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of NSCLC with confirmed squamous or non-squamous tumour histology, without known epidermal growth factor receptor (EGFR) mutation
• Advanced or metastatic disease (Stage IIIb or IV)
• Patients to be treated with cisplatin/gemcitabine or cisplatin/pemetrexed: No previous systemic treatment with chemotherapy, targeted therapy or investigational agents (except adjuvant therapy if > 6 months ago); Patients to be treated with docetaxel: ≥ 1 previous treatment with chemotherapy
• Measurable disease by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
• ECOG performance score 0-1
• Life expectancy ≥ 3 months
• Adequate bone marrow-, renal- and hepatic function
• LVEF ≥ 55% on cardiac ultrasound

Exclusion criteria

• Symptomatic brain metastases
• Gastro-intestinal disorders that could affect drug absorption (including, but not limited to, major abdominal surgery, significant bowel obstruction, ulcerative colitis, Crohn's disease)
• Concurrent treatment with any other systemic anti-cancer therapy
• Serious concomitant uncontrolled medical conditions

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 3 patient groups

Cisplatin, Pemetrexed, Debio 0932

Experimental group

Description:

Cisplatin, Pemetrexed, Debio 0932

Treatment:

Drug: Cisplatin

Drug: Pemetrexed

Drug: Debio 0932

Cisplatin, Gemcitabine, Debio 0932

Experimental group

Description:

Cisplatin, Gemcitabine, Debio 0932

Treatment:

Drug: Gemcitabine

Drug: Cisplatin

Drug: Debio 0932

Docetaxel, Debio 0932

Experimental group

Description:

Docetaxel, Debio 0932

Treatment:

Drug: Docetaxel

Drug: Debio 0932