NCT05209256

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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2022

Typical duration for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

January 26, 2022

Status Verified

October 1, 2021

Enrollment Period

1.8 years

First QC Date

January 9, 2022

Last Update Submit

January 25, 2022

Conditions

NSCLC

Keywords

NSCLC ，EGFR(T790M)，alflutinib

Outcome Measures

Primary Outcomes (1)

  • PFS

    Disease-free survival

    16 weeks

Secondary Outcomes (2)

  • Objective remission rate (ORR)

    16 weeks

  • Disease Control Rate ( DCR)

    16 weeks

Study Arms (2)

Alflutinib plus chemotherapy

EXPERIMENTAL

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.

Drug: Alflutinib plus chemotherapy

chemotherapy

SHAM COMPARATOR

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.

Drug: Chemotherapy

Interventions

ChemotherapyDRUG

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

Also known as: pemetrexed, Pulaile
chemotherapy
Alflutinib plus chemotherapyDRUG

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.

Also known as: AST2818, Pulaile
Alflutinib plus chemotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Garcia-Campelo R, Arrieta O, Massuti B, Rodriguez-Abreu D, Granados ALO, Majem M, Vicente D, Lianes P, Bosch-Barrera J, Insa A, Domine M, Reguart N, Guirado M, Sala MA, Vazquez-Estevez S, Caro RB, Drozdowskyj A, Verdu A, Karachaliou N, Molina-Vila MA, Rosell R; Spanish Lung Cancer Group (SLCG). Combination of gefitinib and olaparib versus gefitinib alone in EGFR mutant non-small-cell lung cancer (NSCLC): A multicenter, randomized phase II study (GOAL). Lung Cancer. 2020 Dec;150:62-69. doi: 10.1016/j.lungcan.2020.09.018. Epub 2020 Oct 3.

    PMID: 33070053BACKGROUND

  • Griesinger F, Eberhardt W, Nusch A, Reiser M, Zahn MO, Maintz C, Bernhardt C, Losem C, Stenzinger A, Heukamp LC, Buttner R, Marschner N, Janicke M, Fleitz A, Spring L, Sahlmann J, Karatas A, Hipper A, Weichert W, Heilmann M, Sadjadian P, Gleiber W, Grah C, Waller CF, Reck M, Rittmeyer A, Christopoulos P, Sebastian M, Thomas M; CRISP Registry Group. Biomarker testing in non-small cell lung cancer in routine care: Analysis of the first 3,717 patients in the German prospective, observational, nation-wide CRISP Registry (AIO-TRK-0315). Lung Cancer. 2021 Feb;152:174-184. doi: 10.1016/j.lungcan.2020.10.012. Epub 2020 Nov 2.

    PMID: 33358484BACKGROUND

  • Hochmair MJ, Morabito A, Hao D, Yang CT, Soo RA, Yang JC, Gucalp R, Halmos B, Marten A, Cufer T. Sequential afatinib and osimertinib in patients with EGFR mutation-positive non-small-cell lung cancer: final analysis of the GioTag study. Future Oncol. 2020 Dec;16(34):2799-2808. doi: 10.2217/fon-2020-0740. Epub 2020 Aug 28.

    PMID: 32854536BACKGROUND

  • Imyanitov EN, Iyevleva AG, Levchenko EV. Molecular testing and targeted therapy for non-small cell lung cancer: Current status and perspectives. Crit Rev Oncol Hematol. 2021 Jan;157:103194. doi: 10.1016/j.critrevonc.2020.103194. Epub 2020 Dec 11.

    PMID: 33316418BACKGROUND

  • Kayatani H, Ohashi K, Ninomiya K, Makimoto G, Nishii K, Higo H, Watanabe H, Kano H, Kato Y, Ninomiya T, Kubo T, Rai K, Ichihara E, Hotta K, Tabata M, Maeda Y, Kiura K. Beneficial effect of erlotinib and trastuzumab emtansine combination in lung tumors harboring EGFR mutations. Biochem Biophys Res Commun. 2020 Nov 12;532(3):341-346. doi: 10.1016/j.bbrc.2020.07.055. Epub 2020 Sep 2.

    PMID: 32888648BACKGROUND

  • Mok TS, Cheng Y, Zhou X, Lee KH, Nakagawa K, Niho S, Chawla A, Rosell R, Corral J, Migliorino MR, Pluzanski A, Noonan K, Tang Y, Pastel M, Wilner KD, Wu YL. Updated Overall Survival in a Randomized Study Comparing Dacomitinib with Gefitinib as First-Line Treatment in Patients with Advanced Non-Small-Cell Lung Cancer and EGFR-Activating Mutations. Drugs. 2021 Feb;81(2):257-266. doi: 10.1007/s40265-020-01441-6.

    PMID: 33331989BACKGROUND

  • Nakahara Y, Matsutani T, Igarashi Y, Matsuo N, Himuro H, Saito H, Yamada K, Murotani K, Hoshino T, Azuma K, Sasada T. Clinical significance of peripheral TCR and BCR repertoire diversity in EGFR/ALK wild-type NSCLC treated with anti-PD-1 antibody. Cancer Immunol Immunother. 2021 Oct;70(10):2881-2892. doi: 10.1007/s00262-021-02900-z. Epub 2021 Mar 9.

    PMID: 33751180BACKGROUND

  • Nakashima K, Ozawa Y, Daga H, Imai H, Tamiya M, Tokito T, Kawamura T, Akamatsu H, Tsuboguchi Y, Takahashi T, Yamamoto N, Mori K, Murakami H. Osimertinib for patients with poor performance status and EGFR T790M mutation-positive advanced non-small cell lung cancer: a phase II clinical trial. Invest New Drugs. 2020 Dec;38(6):1854-1861. doi: 10.1007/s10637-020-00943-0. Epub 2020 May 18.

    PMID: 32424780BACKGROUND

MeSH Terms

Interventions

Drug TherapyPemetrexedaflutinib

Intervention Hierarchy (Ancestors)

TherapeuticsGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Study Officials

  • Xinshuai Wang, PHD

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

    PRINCIPAL INVESTIGATOR

  • Guoqiang Kong, MD

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

    PRINCIPAL INVESTIGATOR

  • Xiaozhi Yuan, MD

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

    PRINCIPAL INVESTIGATOR

  • Jing Ren, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiachun Sun, PHD

CONTACT

18638882757sunjiachun1980@126.com

Tanyou Shan, MD

CONTACT

18537976669shantanyoudoctor@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2022

First Posted

January 26, 2022

Study Start

March 1, 2022

Primary Completion

January 1, 2024

Study Completion

January 1, 2025

Last Updated

January 26, 2022

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share