CClinicalTrials.gg
Sign In
TerminatedNCT04211922Updated Apr 26, 2024

Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib

A Phase 2 interventional study of Alkotinib Capsules in ALK-positive Non-small Cell Lung Cancer, sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd. Terminated at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-26.

Sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Phase 2, Interventional, and Treatment

Why this study was terminated
Sponsor R\&D Strategy Adjustment
Phase
Phase 2
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The main purpose of the study is to evaluate safety and efficacy of Alkotinib capsule in patients with ALK-positive non-small cell lung cancer previously treated with crizotinib.While exploring the relationship between biomarkers and drug efficacy and safety.

Read the detailed description

The drug being tested in this study is called alkotinib. Alkotinib has been demonstrated to benefit people with ALK+ NSCLC.

The study is a non-control study.

The study will enroll approximately 104 participants. All participants will take alkotinib 300mg throughout the study.

This multi-center trial will be conducted in China. The overall time to participate in this study is 3 years. Participants will make multiple visits to the site, and 28 days after last dose of study drug for a follow-up assessment.

02

Conditions studied

  • ALK-positive Non-small Cell Lung Cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 4 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd is the lead sponsor of 82 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Evidence of positive ALK.
  • Patients must have demonstrated progression during or after crizotinib treatment.
  • Age 18 years or older at the time of informed consent.
  • Eastern cooperative oncology group performance status (ECOG PS) of 0-2
  • At least one measurable lesion by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1).
  • Willingness and ability to comply with the trial and follow-up procedures.

Exclusion criteria

Exclusion Criteria:

  • chemotherapy, radiation therapy, immunotherapy within 4 weeks.
  • Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.
  • Uncontrolled mass of pleural effusion, pericardial effusion, and peritoneal effusion
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    Alkotinib 400mg QD

    400mg orally once daily. Take Alkotinib at least 1 hour before or at least 2 hours after a meal.

    Drug: Alkotinib Capsules

Interventions

  • DrugAlkotinib Capsules

    Alkotinib 400mg QD

    Also known as: ZG0418

06

What researchers measure

Primary outcomes

  1. Objective response rate (ORR) based on independent radiology review

    ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR).

    Time frame: 24 months

Secondary outcomes

  1. Progression-free survival (PFS) as assessed by independent radiology review and investigator

    PFS, defined as time from first dose of Alkotinib to progression or death due to any cause.

    Time frame: 36 months

  2. Overall survival (OS)

    OS, defined as time from first dose of Alkotinib to death due to any cause

    Time frame: 36 months

07

Study locations

1 site
  • Shanghai Pulmonary Hospital
    Shanghai, Shanghai 200433, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04211922
Lead sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Responsible party
Sponsor
First posted
Dec 26, 2019
Start date
Jan 21, 2020
Primary completion
Oct 11, 2022
Completion
Oct 11, 2022
Last update
Apr 26, 2024

Study contacts

Caicun Zhou, Doctor
study chair · Shanghai Pulmonary Hospital, Shanghai, China

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lung Neoplasms→

Other studies from this sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Start the discussion