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Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer

ConditionNon-Small Cell Lung Cancer(NSCLC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPingping Song

About this trial

This is a single-arm, exploratory trial to evaluate the efficacy and safety of neoadjuvant WX-0593 in patients with resectable ALK-positive or ROS1- positive non-small cell lung cancer(NSCLC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed non-small cell lung cancer (NSCLC).

ALK-positive or ROS1-positive NSCLC in Stage IB-IIIA (according to the 8th American Joint Committee on Cancer TNM edition), as assessed by investigator.

Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a MDT evaluation (which should include a thoracic surgeon, specialized in oncologic procedures).

ECOG Performance Status of 0-1.

Disqualifiers

Prior treatment with any systemic anti-cancer therapy for NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug.

Prior treatment with ALK TKI or ROS1 TKI.

Prior treatment with local radiotherapy.

Mixed small cell and NSCLC histology.

Trial design

Design model

Single group

Treatments tested in this trial

  • WX-0593 Tablets

    Drug

    60 mg of WX-0593 tablets, once daily for 7 days, followed by 180 mg of WX-0593 tablets, once daily in a 28-days cycle.

Treatment groups

26 Participants
are divided into 1 treatment group
Group A: WX-0593Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Major Pathologic Response (MPR) Rate

Major pathologic response (MPR) rate is defined as percentage of residual viable tumor cells histologically detected in the resected primary tumor after surgery ≤10%.

Time frame
At time of surgery

Secondary outcomes

1

Pathologic Complete Response (pCR) Rate

Pathologic complete response (pCR) rate is defined as the percentage of participants with absence of residual tumor in lung and lymph nodes.

Time frame
At time of surgery
2

Resectability rate

Resectability rate is defined as the percentage of participants who were able to undergo surgery after neoadjuvant therapy.

Time frame
At time of surgery
3

R0 Resection rate

R0 Resection rate is defined as the percentage of participants who were able to undergo R0 Resection surgery after neoadjuvant therapy.

Time frame
At time of surgery
4

Objective Response Rate (ORR)

Objective Response Rate (ORR) is defined as the percentage of participants who have a complete response (CR) or partial response (PR). Responses are according to RECIST 1.1 as assessed by investigator.

Time frame
Prior to surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pingping Song

Lead sponsor

Shandong Cancer Hospital and Institute

Sponsor institution

Source ClinicalTrials.gov
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