New drug combo aims to shrink lung tumors before surgery
NCT ID NCT07550920
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether adding the experimental drug rilapentib alpha to standard chemotherapy can improve outcomes for people with stage II-III non-small cell lung cancer that does not have certain gene mutations. Participants will receive the drug combination before surgery, then continue rilapentib alpha for a year after. The study will measure how many patients have no cancer cells left in their removed tumor tissue and track safety and survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Rilapentib alpha (a drug given by IV) plus single-agent chemotherapy (nab-paclitaxel or pemetrexed)
- What this could lead to
- If it works, this could point toward a new treatment option for people with early-stage lung cancer that lacks certain gene mutations, potentially improving outcomes before and after surgery.
- What could go wrong
- This is a very small, early-phase study (only 18 participants) at a single center, so results may not apply broadly. The drug combination may cause side effects or fail to improve response rates.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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; * 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. Exclusion Criteria: * 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; * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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