Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)

Ono Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Paclitaxel; Drug: Carboplatin; Drug: ONO-4538; Drug: Placebo; Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03117049

ONO-4538-52

Details and patient eligibility

About

The purpose of study is to compare the efficacy and safety of ONO-4538 in combination with carboplatin, paclitaxel, and bevacizumab (ONO-4538 group) to placebo in combination with carboplatin, paclitaxel, and bevacizumab (placebo group) in chemotherapy-naïve subjects with stage IIIB/IV or recurrent non-squamous non-small cell lung cancer unsuitable for radical radiation in a multicenter, randomized, double-blind study.

Enrollment: 550 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with histologically- or cytologically-confirmed non-squamous non-small cell lung cancer
• Subjects who received a diagnosis of stage IIIB/IV or recurrent non-squamous non-small cell lung cancer unsuitable for radical radiation according to the UICC-TNM Classification (7th edition) with no prior systemic anticancer therapy
• Subjects with at least one measurable lesion by radiographic tumor assessments per RECIST 1.1 criteria
• Subjects who are able to provide tumor tissue specimens.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1

Exclusion criteria

• Subjects with known EGFR mutations, including deletions in exon 19 and exon 21 (L858R) substitution mutations.
• Subjects with known ALK translocations.
• Complication or history of severe hypersensitivity reactions to antibody products or platinum-containing compounds
• Subjects with autoimmune disease or known chronic or recurrent autoimmune disease.
• Subjects with multiple cancer.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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550 participants in 2 patient groups, including a placebo group

ONO-4538 group

Experimental group

Description:

ONO-4538: 360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.

Treatment:

Drug: Paclitaxel

Drug: Bevacizumab

Drug: Carboplatin

Drug: ONO-4538

Placebo group

Placebo Comparator group

Description:

Placebo: Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Chemotherapy: Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent. Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.

Treatment:

Drug: Paclitaxel

Drug: Placebo

Drug: Bevacizumab

Drug: Carboplatin