Aumolertinib With Chemotherapy or Alone Compared With Osimertinib in Patients With Epidermal Growth Factor Receptor-Mutant Non-Small Cell Lung Cancer

Conditions

• NSCLC

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Aumolertinib monotherapy — DRUG
  Administered orally, once daily as two 55-mg tablets for a total dose of 110 mg.
• Osimertinib monotherapy — DRUG
  80 mg tablet administered orally, once daily
• Pemetrexed — DRUG
  Administered by IV Infusion per prescribing information. Maybe be continued as maintenance therapy
• Cisplatin — DRUG
  Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information.
• Carboplatin — DRUG
  Administered by IV Infusion given over 4 fixed cycles (q3wk × 4 cycles) per prescribing information.
• Paclitaxel — DRUG
  Administered by IV Infusion given over 4 -6 fixed cycles per prescribing information.
• Nab paclitaxel — DRUG
  Administered by IV Infusion given over 4 fixed cycles per prescribing information.
• Gemcitabine — DRUG
  Administered by IV Infusion over 4 fixed cycles per prescribing information.

Study Details

Aumolertinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets EGFR mutations. The reason for this study is to learn whether adding chemotherapy to a new investigational drug called aumolertinib helps to slow or stop cancer growth in people with EGFR mutation-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC). The study will compare this new combination of drugs to osimertinib, given alone. Aumolertinib given alone will also be used in the study, and it will be looked at in comparison with osimertinib given alone. This is a randomized, open-label study with 3 different groups that are listed below. "Randomized" means the study treatment participants take will be chosen by chance (decided at random by a computer). "Open-label" means that the participant, the study doctor, and the Sponsor will know which study treatment each participant is receiving. Participants will be randomly assigned to one of the following 3 treatment groups: * Group 1: Treatment with aumolertinib alone, taken orally (by mouth) as a pill once a day. Around 100 participants will be randomly assigned to this group. * Group 2: Treatment with aumolertinib taken orally as a pill once a day, in combination with chemotherapy given intravenously (IV; through a needle placed in a vein) on the schedule provided by the study doctor. Around 200 participants will be randomly assigned to this group. * Group 3: Treatment with osimertinib alone, taken orally as a pill once a day. Around 200 participants will be randomly assigned to this group. Because there will be twice as many participants in Group 2 and Group 3 as in Group 1, the chance of a participant being randomly assigned to either of those groups is twice as likely as being assigned to Group 1. Participants can continue to receive study treatment as long as they have not withdrawn consent, as long as they choose to continue to receive study treatment and are judged by their doctor to continue to receive clinical benefit from receiving the study treatment, and as long as no other study treatment and/or study discontinuation criteria are met .

Key Dates

Start date

Dec 14, 2022

Status verified

Oct 2023

Primary completion

Aug 31, 2023

Completion

Aug 31, 2023

Study Design

Enrollment

8 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Aumolertinib monotherapy
• Experimental: Aumolertinib + platinum-based doublet chemotherapy
  For adenocarcinoma, either: * Aumolertinib + cisplatin with pemetrexed, or * Aumolertinib + carboplatin with pemetrexed For squamous cell carcinoma, one of the following: * Aumolertinib + cisplatin or carboplatin with paclitaxel; * Aumolertinib + cisplatin or carboplatin with albumin-bound paclitaxel; or * Aumolertinib + cisplatin or carboplatin with gemcitabine
• Active Comparator: Osimertinib monotherapy

Primary Outcome Measure

Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 5 years ]

Locations (8)

Find similar trials in Springdale, AR

Related Studies

• APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
  PHASE2 · Recruiting · Apollomics Inc. · Los Angeles, California
• A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
  PHASE1/PHASE2 · Recruiting · Merus B.V. · La Jolla, California
• A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer
  PHASE1/PHASE2 · Recruiting · Regeneron Pharmaceuticals · Birmingham, Alabama
• The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
  PHASE1/PHASE2 · Recruiting · PMV Pharmaceuticals, Inc · Irvine, California