Triple threat: new combo aims to stop lung cancer in its tracks
NCT ID NCT03141359
First seen Jun 25, 2026 · Last updated Jul 29, 2026 · Updated 3 times
Summary
This phase II trial tests a three-step approach for stage II or III non-small cell lung cancer. First, the main tumor gets a high-dose radiation blast (SBRT). Then, the chest lymph nodes receive standard radiation plus chemotherapy. Finally, patients get an immunotherapy drug (durvalumab) to help prevent the cancer from coming back. The study enrolled 61 people and is now following them to see how many are alive without cancer progression after one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Durvalumab (immunotherapy), Carboplatin, Paclitaxel, Cisplatin, Etoposide (chemotherapy), and radiation therapy (SBRT, IMRT)
- What this could lead to
- If successful, this combination approach could improve the chance of keeping lung cancer from growing or returning for at least a year.
- What could go wrong
- This is a small, single-arm Phase II trial, so results may not apply broadly. Side effects from radiation, chemotherapy, and immunotherapy can be serious.
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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61 people
The number who actually took part.
- Started
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May 2017
- Expected to finish
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Jul 2027
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 years and older
- 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 Subjects must meet all the following criteria: * Histologic or cytologic documentation of NSCLC (all histologies allowed) * Stage II or III disease (AJCC 7th Edition) based on imaging as required during screening: Stage II disease includes only subjects with medically inoperable N1 disease otherwise meeting eligibility criteria. Primary tumor ≤ 7 cm * Subjects with non-malignant pleural effusion identified on CT scan are eligible provided the effusion is not known or demonstrated to be an exudative effusion. If a pleural effusion is present, the following criteria must be met to exclude malignant involvement: A pleuracentesis is required if pleural fluid is present and visible on both CT scan and chest x-ray. Pleural fluid cytology must be negative for malignancy. Effusions that are minimal and too small for pleuracentesis as determined by the investigator will be eligible for enrollment. * FEV1 ≥ 1.0 Liter or ≥ 40% predicted with or without bronchodilator within six months prior to initiation of study treatment. Subjects who meet the criterion without O2, but who need acute (started within 10 days prior to enrollment) supplemental oxygen due to tumor-caused obstruction/hypoxia are eligible, provided the amount of the O2 needed has been stable. * Age ≥18 years. * ECOG performance status ≤ 2 * Subjects must have normal organ and marrow function as defined: Leukocytes ≥4,000/mcL; Absolute neutrophil count ≥1,500/mcL; Platelets ≥100,000/mcL; Total bilirubin ≤1.5 times the upper limit of normal; Creatinine clearance ≥25 mL/min/1.73 m2 * Negative serum or urine pregnancy test prior to enrollment for women of childbearing age and potential. * The effects of radiation on the developing human fetus are not well described. For this reason, women of child-bearing potential and non-sterilized men who are sexually active with a woman of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. * Must be considered a candidate for durvalumab, per the treating investigator * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria Subjects must not meet any of the following criteria. * Subjects who have had prior systemic therapy for lung cancer * Subjects who have had prior radiation to the region of the chest that would result in overlap of radiation therapy fields and determined by the treating physician to impede the treatment of the study malignancy. * Subjects who are actively being treated on any other interventional research study. * Prior invasive malignancy unless disease free for a minimum of 3 years from enrollment. However, non-melanoma skin cancer, low risk prostate cancer, well differentiated thyroid cancers, in situ carcinomas of the breast, oral cavity, cervix, and other organs, and tumors that are not thought to impact the life expectancy of the subject according to the treating investigator is permissible. * Centrally located primary tumor \< 2 cm from involved nodal disease which would result in significant overlap of radiation dose. Centrally located is defined as within or touching the zone of the proximal bronchial tree, which is a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus right and left lower lobe bronchi).
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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.
Contacts and locations
Locations
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Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
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Other studies related to the condition(s) this trial covers.
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