Clinical trial NCT05351320: WX-0593 Combined With Concurrent Chemoradiotherapy in Unresectable Locally Advanced NSCLC
Official title: A Phase II Study of WX-0593 Combined With Concurrent Chemoradiotherapy in the Treatment of Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) With Activating Mutation of ALK or ROS1
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer (NSCLC)
Keywords: NSCLC, Unresectable , Radiochemotherapy, WX-0593
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this trial is to evaluate the safety of WX-0593 combined with concurrent chemoradiotherapy in unresectable, locally advanced non-small cell lung cancer (NSCLC) with activating mutation of ALK or ROS1. This trial consists of two parts. In Part 1, approximately 8 patients will be included and receive WX-0593 maintenance until disease progression or unacceptable toxicity. In Part 2, approximately 32 patients will be included and receive WX-0593 monotherapy for 1-2 cycles and subsequently with concurrent chemoradiation, followed by WX-0593 maintenance until disease progression or unacceptable toxicity.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 years or older;
* Pathologically confirmed NSCLC who present with investigator-assessed previously untreated, unresectable, locally advanced (Stage II、III) disease (according to TMN staging of AJCC version 8);
* Has active mutation of ALK or ROS1;
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
* Has at least one evaluable lesion (according to RECIST 1.1);
* Have adequate pulmonary function test as a forced expiratory volume in 1 second (FEV1) \>50% of predicted normal volume and carbon monoxide lung diffusing capacity (DLCO) \>40% of predicted normal value;
* Have adequate organ and marrow function;
* If participant is a woman of childbearing potential (WOCBP), must agree to follow the contraceptive guidance from written informed consent until at least 180 days after the last dose of study treatment. The female participant should have negative serum pregnancy test within 7 days prior to the first dose of study drug, and not breastfeeding;
* A male participant must agree to use contraception from written informed consent until at least 180 days after the last dose of study treatment.

Exclusion Criteria:

* Diagnosed other malignant tumor besides NSCLC within 5 years prior to study entry;
* Mixed small cell and non-small cell lung cancer histology;
* Has received prior therapy with any ALK TKI;
* Has a history of extensive diffuse/bilateral interstitial fibrosis, or grade 3 or 4 pulmonary fibrosis or interstitial lung disease prior to the first dose of study drug.

Has a known history of active tuberculosis; severe infection within 4 weeks prior to study entry;

* History of primary immunodeficiency;
* Active or prior documented autoimmune disease within the past 2 years. NOTE: Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.

Primary outcomes:
measure: Percentage of Participants Who Develop Grade 3 or Higher drug-related Pneumonitis
timeFrame: within 90 days after radiation therapy
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 24 months
measure: Overall Survival (OS)
timeFrame: 24 months
measure: Adverse Events (AEs)
timeFrame: 24 months
measure: Disease control rate (DCR)
timeFrame: 24 months
measure: Objective response rate (ORR)
timeFrame: 24 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Cancer Hospital and Institute
state: Shandong
Study officials:
References: