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Study of KN046 With Chemotherapy in First Line Advanced NSCLC

A

Alphamab

Status and phase

Unknown
Phase 2

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: Carboplatin
Drug: Pemetrexed
Biological: KN046
Drug: Paclitaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT04054531
KN046-202

Details and patient eligibility

About

This is a phase II study of KN046 plus platinum-based doublet chemotherapy in previously untreated advanced non-squamous and squamous NSCLC subjects.

The study will assess primarily the safety and efficacy of KN046 plus platinum-based doublet chemotherapy.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Has a histologically or cytologically confirmed diagnosis of stage IV NSCLC;
  • Has not received prior systemic treatment for metastatic NSCLC;
  • Has measurable disease based on RECIST 1.1.
  • Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
  • Has adequate organ function.
  • Has provided tumor tissue from locations not radiated prior to biopsy.

Key Exclusion Criteria:

  • Previous immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways)
  • Previously untreated or symptomatic central nervous system (CNS) metastases
  • Has received a live-virus vaccination within 28 days of planned treatment start.
  • Previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody and chemotherapy.
  • Has or had active autoimmune disease.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

KN046 + carboplatin/paclitaxel
Experimental group
Description:
KN046 5 mg/kg IV every three weeks (Q3W) +Carboplatin AUC5 IV Q3W x 4 cycles + Paclitaxel 500 mg/m2 IV Q3W x 4 cycles
Treatment:
Drug: Paclitaxel
Drug: Carboplatin
Biological: KN046
KN046 + carboplatin/pemetrexed
Experimental group
Description:
KN046 5 mg/kg IV Q3W +Carboplatin AUC5 IV Q3W x 4 cycles + Pemetrexed 500 mg/m2 IV Q3W x 4 cycles
Treatment:
Drug: Carboplatin
Drug: Pemetrexed
Biological: KN046

Trial contacts and locations

1

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Central trial contact

Yun Peng Yang, Doctor

Data sourced from clinicaltrials.gov

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