NSCLC Stage IIIPhase 2NCT07235306
Ensartinib After Chemoradiotherapy in Stage III ALK-Mutated NSCLC
A Phase 2 study testing Ensartinib 225mg in people with NSCLC Stage III and Ensartinib, run by Shanghai Pulmonary Hospital, Shanghai, China.
Trial summary
The PACIFIC study established the standard of care for immunotherapy consolidation after chemoradiotherapy (CRT) in patients with unresectable stage III non-small cell lung cancer (NSCLC). However, its benefit is limited in patients with driver gene mutations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC Stage III, Ensartinib, Chemoradiotherapy
- What is being tested?
- Ensartinib 225mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 31 Dec 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged at least 18 years
- Histologically or cytologically confirmed Stage III unresectable non-small cell lung cancer (NSCLC) with curative treatment intent
- ALK mutations assessed by FISH, IHC, or NGS
- ECOG Performance Status of 0 or 1
- Completion of platinum-based concurrent or sequential chemoradiotherapy as per protocol requirements
- Chemoradiotherapy must have been completed ≤ 6 weeks prior to randomization
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- No disease progression during or after chemoradiotherapy
- Life expectancy > 12 weeks
- Women of childbearing potential must have a negative urine pregnancy test within 7 days prior to initiation of treatment
- Signed informed consent form obtained from the patient or their legally authorized representative
- Male and female patients of childbearing potential agree to use highly effective contraception methods from before entering the trial, throughout the study, and until 8 weeks after discontinuation of study treatment
Who cannot join
- Mixed histology of small cell and non-small cell lung cancer
- Symptomatic pneumonitis following chemoradiotherapy that has not resolved to ≤ Grade 1 (per CTCAE criteria) prior to randomization;
- Any unresolved toxicity from prior chemoradiotherapy with toxicity ≥ Grade 2 (according to CTCAE criteria);
- Poor cardiac function, including but not limited to any of the following:
- Mean resting corrected QT interval (QTc) > 470 msec (obtained from 3 ECGs);
- Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG;
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- Any factors that increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or concomitant use of any known drugs that prolong the QT interval and may lead to Torsades de Pointes;
- Inadequate bone marrow reserve or organ function;
- History of other malignant malignancies, except for adequately treated non-melanoma skin cancer or malignant lentigo, cured carcinoma in situ, or other solid tumors cured > 5 years ago with no evidence of disease and considered by the treating physician to have a low risk of recurrence;
- Severe or uncontrolled systemic diseases: including uncontrolled hypertension and active bleeding tendency; or active infections, including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV);
- Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of ensartinib;
- Any prior chemotherapy, radiotherapy, immunotherapy, or investigational drug therapy beyond the definitive treatment for locally advanced disease;
- Prior treatment with any ALK tyrosine kinase inhibitor (ALK-TKI);
- Major surgery within 4 weeks prior to the first dose of study drug;
- Current use of medications known to be strong inducers of CYP3A4 (which cannot be discontinued at least 3 weeks prior to the first dose of study drug);
- Known hypersensitivity to ensartinib or any excipient in this product;
- Pregnant or lactating women;
- History of definite neurological or psychiatric disorders, including epilepsy or dementia;
- Any other condition that, in the judgment of the investigator, would make the subject unsuitable for participation in the study.
About this study
Official title: Ensartinib for the Treatment of Patients With ALK-Mutated Stage III Unresectable NSCLC: A Multicenter, Randomized Controlled, Double-blind Clinical Study
The PACIFIC study established the standard of care for immunotherapy consolidation after chemoradiotherapy (CRT) in patients with unresectable stage III non-small cell lung cancer (NSCLC). However, its benefit is limited in patients with driver gene mutations. The LAURA study established a new paradigm of targeted consolidation therapy after CRT for patients with EGFR mutations. Although retrospective data support the efficacy of ALK-TKIs, no randomized controlled trial (RCT) has clearly demonstrated the value of ALK-TKI maintenance therapy after CRT. This study adopts a multicenter, randomized, double-blind, placebo-controlled design aimed at evaluating the efficacy and safety of ensartinib in patients with ALK-positive unresectable stage III NSCLC.
- Conditions
- NSCLC Stage III, Ensartinib, Chemoradiotherapy, ALK
- Being tested
- Ensartinib 225mg, Placebo Ensartinib 225mg
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ensartinib 225mgDrug
225mg once daily, until disease progression, unacceptable toxicity or other discontinuation criteria are met
Placebo Ensartinib 225mgDrug
225mg once daily, until disease progression, unacceptable toxicity or other discontinuation criteria are met
| Study group | Role | What they receive |
|---|---|---|
| Ensartinib | Experimental | Ensartinib (225mg orally, once daily), in accordance with the randomization schedule Receives: Drug: Ensartinib 225mg |
| Placebo Ensartinib | Placebo comparator | Matching placebo for Ensartinib (225mg orally, once daily), in accordance with the randomization schedule Receives: Drug: Placebo Ensartinib 225mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
progressive free survival
disease progression according to RSCIST v1.1 or intolerable toxicity according to CTCAE v5.0
Measured: From enrollment to the end of treatment, up to 100 months
Secondary outcomes (5)
Objective Response Rate
ORR is defined as the proportion of participants whose best overall response is complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST 1.1
Measured: From first dose of study drug until disease progression, assessed up to approximately 12 months
Disease Control Rate
DCR is defined as the proportion of participants achieving a best overall response of complete response (CR), partial response (PR), or stable disease (SD) as assessed by the investigator according to RECIST 1.1
Measured: From first dose of study drug until disease progression, assessed up to approximately 12 months
Overall Survival (OS)
OS is defined as the time from randomization until death due to any cause.
Measured: From randomization until death from any cause, up to 120 months
Central Nervous System Progression-Free Survival (CNS-PFS)
CNS-PFS is defined as the time from randomization to the first documented intracranial progression (as assessed by MRI ) or death from any cause, whichever occurs first.
Measured: From randomization until CNS progression or death, up to 100 months
Incidence of Adverse Events (AEs)
AEs graded by CTCAE version 5.0
Measured: Approximately up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 Jan 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IIIStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaping Xu, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235306
- Sponsor's protocol ID
- L25-616
- Status last verified
- Jul 2025
- First submitted
- 23 Sep 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ensartinib for the Treatment of Patients With ALK-Mutated Stage III Unresectable NSCLC: A Multicenter, Randomized Controlled, Double-blind Clinical Study
- ClinicalTrials.gov ID
- NCT07235306
- Acronym / sponsor ID
- L25-616
- Conditions
- NSCLC Stage III, Ensartinib, Chemoradiotherapy, ALK
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Jan 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PACIFIC study established the standard of care for immunotherapy consolidation after chemoradiotherapy (CRT) in patients with unresectable stage III non-small cell lung cancer (NSCLC). However, its benefit is limited in patients with driver gene mutations. The LAURA study established a new paradigm of targeted consolidation therapy after CRT for patients with EGFR mutations. Although retrospective data support the efficacy of ALK-TKIs, no randomized controlled trial (RCT) has clearly demonstrated the value of ALK-TKI maintenance therapy after CRT. This study adopts a multicenter, randomized, double-blind, placebo-controlled design aimed at evaluating the efficacy and safety of ensartinib in patients with ALK-positive unresectable stage III NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ensartinib | Experimental | Drug: Ensartinib 225mgEnsartinib (225mg orally, once daily), in accordance with the randomization schedule |
| Placebo Ensartinib | Placebo comparator | Drug: Placebo Ensartinib 225mgMatching placebo for Ensartinib (225mg orally, once daily), in accordance with the randomization schedule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female aged at least 18 years
- Histologically or cytologically confirmed Stage III unresectable non-small cell lung cancer (NSCLC) with curative treatment intent
- ALK mutations assessed by FISH, IHC, or NGS
- ECOG Performance Status of 0 or 1
- Completion of platinum-based concurrent or sequential chemoradiotherapy as per protocol requirements
Key exclusion criteria (19 listed)
- Mixed histology of small cell and non-small cell lung cancer
- Symptomatic pneumonitis following chemoradiotherapy that has not resolved to ≤ Grade 1 (per CTCAE criteria) prior to randomization;
- Any unresolved toxicity from prior chemoradiotherapy with toxicity ≥ Grade 2 (according to CTCAE criteria);
- Poor cardiac function, including but not limited to any of the following:
- Inadequate bone marrow reserve or organ function;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ensartinib 225mg225mg once daily, until disease progression, unacceptable toxicity or other discontinuation criteria are met | Drug | Ensartinib |
| Placebo Ensartinib 225mg225mg once daily, until disease progression, unacceptable toxicity or other discontinuation criteria are met | Drug | Placebo Ensartinib |
Primary outcome
progressive free survival
Time frame: From enrollment to the end of treatment, up to 100 months
disease progression according to RSCIST v1.1 or intolerable toxicity according to CTCAE v5.0
5 secondary outcomes
Objective Response Rate
Time frame: From first dose of study drug until disease progression, assessed up to approximately 12 months
Disease Control Rate
Time frame: From first dose of study drug until disease progression, assessed up to approximately 12 months
Overall Survival (OS)
Time frame: From randomization until death from any cause, up to 120 months
Central Nervous System Progression-Free Survival (CNS-PFS)
Time frame: From randomization until CNS progression or death, up to 100 months
Incidence of Adverse Events (AEs)
Time frame: Approximately up to 100 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ensartinib 225mg in people with NSCLC Stage III and Ensartinib, run by Shanghai Pulmonary Hospital, Shanghai, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progressive free survival (time frame: From enrollment to the end of treatment, up to 100 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.