D-0316 Versus Icotinib in Patients With Locally Advanced or Metastatic EGFR Sensitising Mutation Positive NSCLC

Browse trials for

• Carcinoma, Non-Small-Cell Lung 6,488

Keywords

• D-0316
• EGFR mutated NSCLC

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.

This study's enrollment of 362 is above the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Lead sponsor

Betta Pharmaceuticals Co., Ltd. is the lead sponsor of 79 studies on the registry; 19 are open to participants now.

Study arms

• Experimental
  D-0316

  D-0316 (75 mg or 100 mg orally, once daily), in accordance with the randomization schedule.

  Drug: D-0316 Capsule

• Active comparator
  Icotinib

  Icotinib (125 mg orally, three times daily), in accordance with the randomization schedule.

  Drug: Icotinib Hydrochloride Tablets

Interventions

• DrugD-0316 Capsule

  The initial dose of D-0316 is 75 mg orally once daily (QD) for one cycle, and then increased to 100 mg orally QD in the absence of CTCAE grade ≥ 2 headache or thrombocytopenia during the first cycle, otherwise maintained to 75 mg orally QD until disease progression or meet the discontinuation criteria. A cycle of treatment is defined as 21 days of once daily treatment. Following objective disease progression according to RECIST 1.1, as per investigator assessment, patients who were confirmed T790M mutation positive may have the option to continuously receive D-0316.

• DrugIcotinib Hydrochloride Tablets

  Icotinib (125 mg three times daily, orally), treatment should continue until disease progression or meet the withdrawal criteria. A cycle of treatment is defined as 21 days of three times daily treatment. Following objective disease progression according to RECIST 1.1, as per investigator assessment, patients who were randomized to Icotinib arm and confirmed T790M mutation positive have the option to receive D-0316 (crossover to active D-0316).

  Also known as: Conmana

Primary outcomes

1. Median Progression Free Survival (PFS) assessed by IRC

   PFS is defined as the time from randomization until the date of objective disease progression or death by any cause, whichever occurs first. The primary endpoint of PFS was based on independent review committee (IRC) assessment.

   Time frame: From randomization to objective disease progression or death, whichever came first, assessed up to 20 months

Secondary outcomes

1. Median Progression Free Survival (PFS) assessed by Investigator

   PFS is defined as the time from randomization until the date of objective disease progression or death by any cause, whichever occurs first.

   Time frame: From randomization to objective disease progression or death, whichever came first, assessed up to 20 months

2. Objective Response Rate (ORR)

   ORR is defined as the percentage (%) of participants with measurable disease with a best overall response of complete response (CR) or partial response (PR). ORR was based on investigator and IRC assessment.

   Time frame: At baseline and every 6 weeks (±4 days) until disease progression, up to 20 months

3. Duration of Response (DoR)

   DoR is defined as the time from the date of first documented response (CR or PR) until the date of documented progression or death in the absence of disease progression. DoR was based on both Investigator and IRC assessment.

   Time frame: At baseline and every 6 weeks (±4 days) until disease progression, up to 20 months

4. Disease Control Rate (DCR)

   DCR is defined as the percentage (%) of participants who had a best overall response (BOR) of CR, PR or Stable disease (SD) ≥6 weeks prior to any progressive disease (PD) event, assessed by investigator and IRC.

   Time frame: At baseline and every 6 weeks (±4 days) until disease progression, up to 20 months

5. Overall Survival (OS)

   OS is defined as the time from randomization until the date of death due to any cause.

   Time frame: From randomization to date of death from any cause, whichever came first, up to 36 months

6. Intracranial ORR (iORR)

   iORR is calculated as the ORR (CR+PR) of lesions in the brain for patients who have measurable disease in the brain at baseline. iORR was based on both Investigator and IRC assessment.

   Time frame: At baseline and every 6 weeks (±4 days) until disease progression, up to 20 months

7. Intracranial PFS (iPFS)

   iPFS is defined as time from randomization to intracranial disease progression or death due to any causes, assessed by investigator and IRC.

   Time frame: From randomization to objective intracranial disease progression or death, whichever came first, up to 20 months

8. Adverse event (AE)

   AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study medication, whether or not considered related to the study medication. AEs are summarized by type, incidence, severity and relationship to study medication.

   Time frame: At baseline and every 3 weeks (±4 days) for the first 6 weeks, and then every 6 weeks (±4 days) until objective disease progression or meet other withdrawal criteria, up to 36 months

Other outcomes

1. Change From Baseline Scores on the functional assessment of cancer therapy - Lung (FACT-L) quality of life questionnaire

   The FACT-L questionnaire consists of several major aspects of life (Physical, social/family, emotional, and functional well-being) as well as lung cancer subscale (symptoms, cognitive function, regret of smoking). Scores for item ranging from 0 (not at all) to 4 (very much).

   Time frame: At baseline and every 6 weeks (±4 days) until disease progression, up to 20 months

Publications

• Lu S, Zhou J, Jian H, Wu L, Cheng Y, Fan Y, Fang J, Chen G, Zhang Z, Lv D, Jiang L, Wu R, Jin X, Zhang X, Zhang J, Xie C, Sun G, Huang D, Cui J, Guo R, Han Z, Chen Z, Liang J, Zhuang W, Hu X, Zang A, Zhang Y, Cang S, Lan Y, Chen X, Liu L, Li X, Chen J, Ma R, Guo Y, Sun P, Tian P, Pan Y, Liu Z, Cao P, Ding L, Wang Y, Yuan X, Wu P. Befotertinib (D-0316) versus icotinib as first-line therapy for patients with EGFR-mutated locally advanced or metastatic non-small-cell lung cancer: a multicentre, open-label, randomised phase 3 study. Lancet Respir Med. 2023 Oct;11(10):905-915. doi: 10.1016/S2213-2600(23)00183-2. Epub 2023 May 24. PubMed 37244266 ↗
• Lu S, Zhang Y, Zhang G, Zhou J, Cang S, Cheng Y, Wu G, Cao P, Lv D, Jian H, Chen C, Jin X, Tian P, Wang K, Jiang G, Chen G, Chen Q, Zhao H, Ding C, Guo R, Sun G, Wang B, Jiang L, Liu Z, Fang J, Yang J, Zhuang W, Liu Y, Zhang J, Pan Y, Chen J, Yu Q, Zhao M, Cui J, Li D, Yi T, Yu Z, Yang Y, Zhang Y, Zhi X, Huang Y, Wu R, Chen L, Zang A, Cao L, Li Q, Li X, Song Y, Wang D, Zhang S, Ding L, Zhang L, Yuan X, Yao L, Shen Z. Efficacy and Safety of Befotertinib (D-0316) in Patients With EGFR T790M-Mutated NSCLC That Had Progressed After Prior EGFR Tyrosine Kinase Inhibitor Therapy: A Phase 2, Multicenter, Single-Arm, Open-Label Study. J Thorac Oncol. 2022 Oct;17(10):1192-1204. doi: 10.1016/j.jtho.2022.06.002. Epub 2022 Jun 18. PubMed 35724798 ↗