Real-world Study of Taletrectinib in Advanced ROS1+ NSCLC Following Entrectinib Progression

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInnovent Biologics (Suzhou) Co. Ltd.

About this trial

This is a multicenter, non-interventional, observational real-world study to evaluate the efficacy and safety of Taletrectinib in ROS1-positive non-small cell lung cancer (NSCLC) following Entrectinib progression. Patients deemed eligible for Taletrectinib by their physicians were enrolled after providing informed consent. Taletrectinib will be administered according to clinical practice and data on treatment patterns, clinical outcomes, and safety will be collected during routine evaluations.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Histologically or cytologically metastatic NSCLC (UICC/AJCC TNM Staging System, 9th Edition, Stage Ⅳ).

At least one measurable target tumor lesion as accessed by RECIST v1.1 criteria.

Documented ROS1 gene fusion identified by an approved molecular testing method (FISH, RT-PCR, or NGS).

Disqualifiers

Patients with driver gene mutations/alterations that have approved targeted therapies , including but not limited to EGFR, ALK, RET, etc.

Currently participating in other interventional clinical trials or having received investigational drug treatment within 4 weeks prior to enrollment .

Pregnancy or breastfeeding.

Patients with uncontrolled co-morbidities who are assessed by the investigator not to receive targeted therapy.

Trial population

Patients with ROS1-positive non-small cell lung cancer (NSCLC) who progressed following Entrectinib treatment

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Taletrectinib

    Drug

    Taletrectinib, 600mg, QD

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Cohort 11 intervention

Trial outcomes

Primary outcomes

1

ORR

Objective response rate

Time frame
6 months

Secondary outcomes

1

PFS

Description: Progression free survival

Time frame
25 months
2

DoR

Duration of response

Time frame
25 months
3

DCR

Disease control rate

Time frame
6 months
4

OS

Overall survival

Time frame
51 months

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: