QUILT-2.017: Phase 1b/2 Study of AMG 479 in Combination With Paclitaxel and Carboplatin for 1st Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer

NantCell

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Advanced Squamous Non-Small Cell Lung Cancer

Treatments: Drug: Paclitaxel; Biological: AMG 479; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00807612

20080257

QUILT-2.017 (Other Identifier)

Details and patient eligibility

About

This is a global, multicenter, 2-part, open-label phase 1b and single-arm phase 2 study designed to evaluate the safety and efficacy of AMG 479 in combination with paclitaxel and carboplatin for the first-line treatment of advanced squamous non-small cell lung carcinoma.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed advanced squamous NSCLC
• Measurable disease as defined per modified RECIST criteria
• ECOG performance status of 0 or 1
• ≥18 years old
• Adequate glycemic function, for subjects with known diabetes

Exclusion criteria

• Untreated or symptomatic central nervous system (CNS) metastases
• Prior anti-cancer therapy as follows: Any prior chemotherapy for squamous NSCLC; Any prior adjuvant or neoadjuvant chemotherapy for squamous NSCLC; Any prior chemoradiation for squamous NSCLC; Central (chest) radiation therapy ≤ 28 days prior to enrollment, radiation therapy for peripheral lesions≤14 days prior to enrollment for squamous NSCLC

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Part 1 Cohort 1

Experimental group

Description:

AMG 479 at 18 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 18 mg/kg monotherapy for 24 months from study day 1

Treatment:

Drug: Carboplatin

Biological: AMG 479

Biological: AMG 479

Biological: AMG 479

Drug: Paclitaxel

Part 1 Cohort 2

Experimental group

Description:

AMG 479 at 12 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 12 mg/kg monotherapy for 24 months from study day 1

Treatment:

Drug: Carboplatin

Biological: AMG 479

Biological: AMG 479

Biological: AMG 479

Drug: Paclitaxel

Part 2

Experimental group

Description:

AMG 479 in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 monotherapy for 24 months from study day 1 (AMG 479 dose in Part 2 will be the final AMG 479 dose from Part 1)

Treatment:

Drug: Carboplatin

Biological: AMG 479

Biological: AMG 479

Biological: AMG 479

Drug: Paclitaxel