Alflutinib Versus Alflutinib Plus Chemotherapy for NSCLC

NCT ID: NCT05209256

Last Updated: 2022-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2025-01-31

Brief Summary

Aim: the aim of this study is to investigated whether the combination of alflutinib with cytotoxic chemotherapy might hold additive efficacy, as well as tolerability .

Detailed Description

alflutinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that is active in the central nervous system (CNS) and which potently and selectively inhibits mutant forms of EGFR with both TKI-sensitising (activating) mutations and the T790M resistance-conferring mutation. However, resistance to alflutinib inevitably emerges. One promising strategy to further improve patient prognosis and to approach a cure is combination therapy with alflutinib and other agents such as cytotoxic chemotherapeutic drugs.

Conditions

NSCLC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Alflutinib plus chemotherapy

Those in the combination group received concurrent alflutinib (80 mg daily), as well as carboplatin (area under the curve \[AUC\] of 5 on day 1) and pemetrexed (500 mg/m2 on day 1) in a 3-week cycle for up to four cycles, followed by maintenance on alflutinib and pemetrexed until disease progression, unacceptable toxicity, or death.

Group Type: EXPERIMENTAL

Alflutinib plus chemotherapy

Intervention Type: DRUG

Those in the combination group received concurrent alflutinib (80 mg daily), as well as carboplatin (area under the curve \[AUC\] of 5 on day 1) and pemetrexed (500 mg/m2 on day 1) in a 3-week cycle for up to four cycles, followed by maintenance on alflutinib and pemetrexed until disease progression, unacceptable toxicity, or death.

chemotherapy

arboplatin (area under the curve \[AUC\] of 5 on day 1) and pemetrexed (500 mg/m2 on day 1) in a 3-week cycle for up to four cycles, followed by maintenance on alflutinib and pemetrexed until disease progression, unacceptable toxicity, or death.

Group Type: SHAM_COMPARATOR

Chemotherapy

Intervention Type: DRUG

Patients in the alflutinib group received alflutinib (80 mg daily) until disease progression, unacceptable toxicity, or death.

Interventions

Chemotherapy

Patients in the alflutinib group received alflutinib (80 mg daily) until disease progression, unacceptable toxicity, or death.

Intervention Type: DRUG

Alflutinib plus chemotherapy

Those in the combination group received concurrent alflutinib (80 mg daily), as well as carboplatin (area under the curve \[AUC\] of 5 on day 1) and pemetrexed (500 mg/m2 on day 1) in a 3-week cycle for up to four cycles, followed by maintenance on alflutinib and pemetrexed until disease progression, unacceptable toxicity, or death.

Intervention Type: DRUG

Other Intervention Names

pemetrexed; Pulaile; AST2818; Pulaile

Eligibility Criteria

Inclusion Criteria

• histologically or cytologically diagnosed non-squamous NSCLC of stage IIIB or IV (based on the 7th edition of the TNM classification) or recurrent;
• an EGFR mutation, including an exon-19 deletion (Ex19del), L858R, or other (L861Q, G719A, G719C, or G719S), as well as the T790M mutation of EGFR as detected in a tissue or liquid biopsy sample obtained after disease progression during first-line EGFR-TKI (gefitinib, erlotinib, or afatinib) treatment;
• WHO performance status of 0 or 1;
• no prior neoadjuvant or adjuvant chemotherapy in the 12 months preceding study enrollment;
• adequate bone marrow reserve and organ function.

Exclusion Criteria

• treatment with an EGFR-TKI within 7 days of the first dose of the study treatment;
• symptomatic CNS metastases;
• evidence of interstitial pneumonia, pulmonary fibrosis, or radiation pneumonitis requiring steroid treatment as revealed by a computed tomography (CT) scan.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Henan University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xinshuai Wang, PHD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Clinical Medicine of Henan University of Science and Technology

Guoqiang Kong, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Clinical Medicine of Henan University of Science and Technology

Xiaozhi Yuan, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Clinical Medicine of Henan University of Science and Technology

Jing Ren, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Clinical Medicine of Henan University of Science and Technology

Central Contacts

Jiachun Sun, PHD

Role: CONTACT

sunjiachun1980@126.com

18638882757

Tanyou Shan, MD

Role: CONTACT

shantanyoudoctor@163.com

18537976669

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Other Identifiers

ALF-IN-NSCLC-001

Identifier Type: -

Identifier Source: org_study_id