NSCLCPhase 2NCT07550920
Relatrilfa-α Plus Single-Agent Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III NSCLC (Phase 2)
A Phase 2 study testing Drug: Retlirafusp alfa, Drug: Single-agent Chemotherapy and Procedure: Radical Surgery in people with NSCLC, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
This is a single-center, single-arm, phase 2 trial evaluating the efficacy and safety of retlirafusp alfa combined with single-agent chemotherapy as neoadjuvant treatment for patients with resectable stage II-III EGFR/ALK wild-type non-small cell lung cancer (NSCLC).Eligible patients receive 4 cycles of neoadjuvant… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- Drug: Retlirafusp alfa, Drug: Single-agent Chemotherapy and Procedure: Radical Surgery
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2026to 30 Jan 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- ECOG Performance Status 0-1;
- Treatment-naive patients with histologically or cytologically confirmed NSCLC (via biopsy) and radiologically confirmed Stage II-III disease;
- Patients with adenocarcinoma must be confirmed to be free of driver gene mutations such as EGFR or ALK; patients with squamous cell carcinoma do not require genetic testing;
- Patients must have measurable lesions;
- Patients whose disease was assessed as CR, PR, or SD following 2 cycles of neoadjuvant chemotherapy with Rilpufan α in combination with a single-agent non-platinum chemotherapy;
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- Life expectancy of at least 12 weeks;
- Good function of other major organs (liver, kidneys, hematopoietic system, etc.): - Hemoglobin ≥ 9.0 g/dL (this level may be maintained or exceeded through blood transfusion); - Red blood cell count ≥ 2.0 × 10⁹/L; - Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L; - Platelet count ≥ 100 × 10⁹/L; - Total bilirubin within normal limits; - Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase ≤ 2.5 times the upper limit of normal; - Creatinine ≤ 2.0 mg/dL; and creatinine clearance ≥ 60 mL/min; - For patients who have not received anticoagulant therapy: International Normalized Ratio (INR) for prothrombin time ≤ 1.5, and activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal. Patients receiving full-dose or parenteral anticoagulant therapy may be enrolled in the clinical trial provided that the anticoagulant dose has been stable for at least 2 weeks prior to study entry and the results of coagulation tests fall within the limits established by the local treatment center.
- No systemic metastases;
- Expected to be completely resectable;
- Good pulmonary function sufficient to tolerate surgical treatment;
- Women of childbearing potential must undergo a pregnancy test within 7 days prior to the start of treatment and receive a negative result;
- Participants must use reliable contraception (e.g., intrauterine device, oral contraceptives, and condoms) during the trial and for 30 days after its completion; 14 Participants voluntarily enroll in the study, sign an informed consent form, demonstrate good compliance, and cooperate with follow-up.
Who cannot join
- Any systemic anticancer therapy for NSCLC, other than neoadjuvant therapy as specified in the inclusion criteria, including surgery, local radiotherapy, cytotoxic drug therapy, targeted drug therapy, and experimental treatments;
- Patients who have had a cancer other than NSCLC within five years prior to the start of this trial;
- Patients with unstable systemic diseases, such as uncontrolled hypertension or severe arrhythmias;
- Patients with active, known, or suspected autoimmune diseases;
- Patients with a history of or current interstitial lung disease;
- Patients with HIV infection;
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- Patients who have undergone major systemic surgery or suffered severe trauma within 2 months prior to the start of this trial;
- Pregnant or breastfeeding women;
- Patients with neurological or psychiatric disorders who are unable to comply with the study protocol;
- Other circumstances deemed unsuitable for enrollment by the investigator
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Rilapentib Alpha Combined With Monotherapy Chemotherapy for the Perioperative Treatment of Resectable Stage II-III Driver Gene-Negative Non-Small Cell Lung Cancer (NSCLC): A Single-Center Phase II Study
This is a single-center, single-arm, phase 2 trial evaluating the efficacy and safety of retlirafusp alfa combined with single-agent chemotherapy as neoadjuvant treatment for patients with resectable stage II-III EGFR/ALK wild-type non-small cell lung cancer (NSCLC).Eligible patients receive 4 cycles of neoadjuvant therapy, followed by curative surgery and 1-year maintenance therapy with retlirafusp alfa.Primary endpoints are pathological complete response (pCR) rate and safety. Secondary endpoints include major pathological response (MPR), event-free survival (EFS), and overall survival (OS).
- Conditions
- NSCLC
- Being tested
- Drug: Retlirafusp alfa, Drug: Single-agent Chemotherapy, Procedure: Radical Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: Retlirafusp alfaDrug
30mg/kg intravenously every 3 weeks (Q3W) for neoadjuvant and maintenance therapy
Drug: Single-agent ChemotherapyDrug
Nab-paclitaxel or pemetrexed (per histology), intravenously Q3W
Procedure: Radical SurgeryOther
Radical resection of lung cancer after neoadjuvant therapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Retlirafusp alfa + Single-agent Chemotherapy | Experimental | Not described Receives: Drug: Drug: Retlirafusp alfa; Drug: Drug: Single-agent Chemotherapy; Other: Procedure: Radical Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR) Rate
Measured: Assessed at the time of surgery, approximately 6-8 weeks after completion of neoadjuvant therapy.
Secondary outcomes (12)
Major Pathological Response (MPR) Rate
Measured: Assessed at the time of surgery.
Event-Free Survival (EFS)
Measured: Assessed from randomization up to 36 months post-surgery.
Overall Survival (OS)
The time from randomization to death from any cause.
Measured: From the start of randomization until the study end date (expected January 30, 2028)
Pathological Response (PR) Rate
Measured: Assessed at the time of surgery.
R0 resection rate
The percentage of patients with no residual tumor at the surgical margin.
Measured: Assessment within 24 hours after surgery
Changes in EORTC QLQ-C30 Scores
Patients completed the EORTC QLQ-C30 questionnaire to assess changes from baseline in scores across the functional domains (physical, role, emotional, cognitive, and social) and the symptom domain. The total score on the questionnaire is 100; higher scores in the functional domains indicate better quality of life, while higher scores in the symptom domain indicate more severe symptoms.
Measured: Baseline; before each cycle of neoadjuvant therapy; at the time of surgery; 3, 6, and 12 months post-surgery
Recurrence-Free Survival (RFS)
Measured: Assessed from surgery up to 5 years post-surgery.
Number of positive lymph nodes
The total number of lymph nodes that tested positive on pathological examination in the surgical specimen.
Measured: Assessment will be conducted after the surgery, once the pathology report is available.
Incidence of severe postoperative complications (Clavien-Dindo classification ≥ Grade III)
The proportion of patients who experienced severe complications classified as Clavien-Dindo grade ≥III within 30 days postoperatively.
Measured: Continuous monitoring from the time of surgery through 30 days postoperatively.
Incidence and severity of adverse events (CTCAE v6.0)
In accordance with the CTCAE v6.0 criteria, assess the incidence and severity grading of all adverse events occurring during treatment.
Measured: The period is calculated from the first administration of the study drug until 30 days after the last dose; for delayed adverse reactions, the period is calculated until 1 year after the last dose.
Percentage of patients whose dosage was adjusted due to adverse events
The proportion of patients who required dose reduction or treatment interruption due to adverse events out of the total number of enrolled patients.
Measured: Calculated from the start of the first treatment with the study drug until 30 days after the last dose.
Changes in EORTC QLQ-LC13 Scores
Patients completed the EORTC QLQ-LC13 questionnaire to assess changes in scores for lung cancer-related symptoms (such as cough, shortness of breath, and pain) compared to baseline. The scale is scored out of 100, with higher scores indicating more severe symptoms.
Measured: Baseline; before each cycle of neoadjuvant therapy; at the time of surgery; 3, 6, and 12 months post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start10 May 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550920
- Sponsor's protocol ID
- NSCLC-NEO-001
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Rilapentib Alpha Combined With Monotherapy Chemotherapy for the Perioperative Treatment of Resectable Stage II-III Driver Gene-Negative Non-Small Cell Lung Cancer (NSCLC): A Single-Center Phase II Study
- ClinicalTrials.gov ID
- NCT07550920
- Acronym / sponsor ID
- NSCLC-NEO-001
- Conditions
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 10 May 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 24 Apr 2026 (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.
This is a single-center, single-arm, phase 2 trial evaluating the efficacy and safety of retlirafusp alfa combined with single-agent chemotherapy as neoadjuvant treatment for patients with resectable stage II-III EGFR/ALK wild-type non-small cell lung cancer (NSCLC).Eligible patients receive 4 cycles of neoadjuvant therapy, followed by curative surgery and 1-year maintenance therapy with retlirafusp alfa.Primary endpoints are pathological complete response (pCR) rate and safety. Secondary endpoints include major pathological response (MPR), event-free survival (EFS), and overall survival (OS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Retlirafusp alfa + Single-agent Chemotherapy | Experimental | Drug: Drug: Retlirafusp alfa, Drug: Drug: Single-agent Chemotherapy, Other: Procedure: Radical Surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18-75 years
- ECOG Performance Status 0-1;
- Treatment-naive patients with histologically or cytologically confirmed NSCLC (via biopsy) and radiologically confirmed Stage II-III disease;
- Patients with adenocarcinoma must be confirmed to be free of driver gene mutations such as EGFR or ALK; patients with squamous cell carcinoma do not require genetic testing;
- Patients must have measurable lesions;
Key exclusion criteria (10 listed)
- Any systemic anticancer therapy for NSCLC, other than neoadjuvant therapy as specified in the inclusion criteria, including surgery, local radiotherapy, cytotoxic drug therapy, targeted drug therapy, and experimental treatments;
- Patients who have had a cancer other than NSCLC within five years prior to the start of this trial;
- Patients with unstable systemic diseases, such as uncontrolled hypertension or severe arrhythmias;
- Patients with active, known, or suspected autoimmune diseases;
- Patients with a history of or current interstitial lung disease;
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 |
|---|---|---|
| Drug: Retlirafusp alfa30mg/kg intravenously every 3 weeks (Q3W) for neoadjuvant and maintenance therapy | Drug | Experimental: Retlirafusp alfa + Single-agent Chemotherapy |
| Drug: Single-agent ChemotherapyNab-paclitaxel or pemetrexed (per histology), intravenously Q3W | Drug | Experimental: Retlirafusp alfa + Single-agent Chemotherapy |
| Procedure: Radical SurgeryRadical resection of lung cancer after neoadjuvant therapy | Other | Experimental: Retlirafusp alfa + Single-agent Chemotherapy |
Primary outcome
Pathological Complete Response (pCR) Rate
Time frame: Assessed at the time of surgery, approximately 6-8 weeks after completion of neoadjuvant therapy.
12 secondary outcomes
Major Pathological Response (MPR) Rate
Time frame: Assessed at the time of surgery.
Event-Free Survival (EFS)
Time frame: Assessed from randomization up to 36 months post-surgery.
Overall Survival (OS)
Time frame: From the start of randomization until the study end date (expected January 30, 2028)
Pathological Response (PR) Rate
Time frame: Assessed at the time of surgery.
R0 resection rate
Time frame: Assessment within 24 hours after surgery
Changes in EORTC QLQ-C30 Scores
Time frame: Baseline; before each cycle of neoadjuvant therapy; at the time of surgery; 3, 6, and 12 months post-surgery
Recurrence-Free Survival (RFS)
Time frame: Assessed from surgery up to 5 years post-surgery.
Number of positive lymph nodes
Time frame: Assessment will be conducted after the surgery, once the pathology report is available.
Incidence of severe postoperative complications (Clavien-Dindo classification ≥ Grade III)
Time frame: Continuous monitoring from the time of surgery through 30 days postoperatively.
Incidence and severity of adverse events (CTCAE v6.0)
Time frame: The period is calculated from the first administration of the study drug until 30 days after the last dose; for delayed adverse reactions, the period is calculated until 1 year after the last dose.
Percentage of patients whose dosage was adjusted due to adverse events
Time frame: Calculated from the start of the first treatment with the study drug until 30 days after the last dose.
Changes in EORTC QLQ-LC13 Scores
Time frame: Baseline; before each cycle of neoadjuvant therapy; at the time of surgery; 3, 6, and 12 months post-surgery.
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 24 Apr 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Drug: Retlirafusp alfa, Drug: Single-agent Chemotherapy and Procedure: Radical Surgery in people with NSCLC, run by Tianjin Medical University Cancer Institute and Hospital.
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 13 inclusion and 10 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 24 Apr 2026. 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. 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?
Contact Zhenfa Zhang Zhenfa Zhang (+8613821561246, zhangzhenfa1973@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) Rate (time frame: Assessed at the time of surgery, approximately 6-8 weeks after completion of neoadjuvant therapy.). 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 24 Apr 2026; AzTrials last refreshed its copy on 30 Oct 2026.