Clinical trial · Interventional

Alflutinib Versus Alflutinib Plus Chemotherapy for NSCLC

Alflutinib Versus Alflutinib Plus Chemotherapy for Nonesmall Cell Lung Cancer With EGFR (T790M)- Associated Resistance to Initial EGFR Inhibitor Treatment: An Open-label, Randomised Phase 2 Clinical Trial

NCT05209256CI-TRIAL-00056158unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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 .

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
NSCLC	Lung Non-Small Cell Carcinoma	ALIAS	0.90

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Alflutinib plus chemotherapy	Drug	—	UNRESOLVED
Chemotherapy	Drug	Chemotherapy	ALIAS

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Alflutinib plus chemotherapy
description
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.
interventionNames
1. Drug: Alflutinib plus chemotherapy
type
SHAM_COMPARATOR
label
chemotherapy
description
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.
interventionNames
1. Drug: Chemotherapy

Primary outcomes (1)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

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.

References

Publications (8)

BACKGROUNDGarcia-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 33070053
BACKGROUNDGriesinger 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 33358484
BACKGROUNDHochmair 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 32854536
BACKGROUNDImyanitov 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 33316418
BACKGROUNDKayatani 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.