New combo therapy aims to clear lung cancer before surgery
NCT ID NCT03838159
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tests whether adding immunotherapy to standard chemotherapy before surgery helps eliminate more lung cancer in patients with advanced, but potentially removable, non-small cell lung cancer. 90 participants will be randomly assigned to receive either chemo-immunotherapy or chemotherapy alone. The main goal is to see if the combination leads to a higher rate of complete tumor disappearance in the lung and lymph nodes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Paclitaxel (chemotherapy) plus an immunotherapy drug (not specified in the provided data)
- What this could lead to
- If successful, this approach could increase the chance of removing all cancer before surgery, potentially improving long-term outcomes for patients with advanced lung cancer.
- What could go wrong
- This is a phase II trial with only 90 participants, so results are preliminary. Adding immunotherapy to chemotherapy may increase side effects, and not all patients may benefit.
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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90 people
The number who actually took part.
- Started
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May 2019
- Expected to finish
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Nov 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 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: 1. Previously untreated patients with histologically- or cytologically- documented NSCLC who present stage IIIA disease (according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) and also, potentially resectable locally advanced NSCLC patients' stage IIIB with T3N2 disease according to 8th edition can be included. * PET/CT including IV contrast (CT of diagnostic quality) will be performed at baseline (28 days +10 before randomization) 2. Tumor should be considered resectable before study entry by a multidisciplinary team 3. ECOG (Performance status) 0-1 4. Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to randomization. i. Neutrophils ≥ 1500×109/L ii. Platelets ≥ 100 x×109/L iii. Hemoglobin \> 9.0 g/dL iv. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min v. AST/ALT ≤ 3 x ULN vi. Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL) vii. The patients need to have a forced expiratory volume (FEV1) ≥ 1.2 liters or \>40% predicted value viii. INR/APTT within normal limits 5. All patients are notified of the investigational nature of this study and signed a written informed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention 6. Patients aged \> 18 years 7. Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 7 days before randomization. 8. All sexually active men and women of childbearing potential must use an effective contraceptive method (two barrier methods or a barrier method plus a hormonal method) during the study treatment and for a period of at least 12 months following the last administration of trial drugs 9. Patient capable of proper therapeutic compliance and accessible for correct follow-up 10. Measurable or evaluable disease (according to RECIST 1.1 criteria) Exclusion Criteria: 1. All patients carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene. 2. Patients with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement or unexpected conditions of recurrence in the absence of an external trigger are allowed to be included. 3. Patients with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. 4. Patients with a history of interstitial lung disease cannot be included if they have symptomatic ILD (Grade 3-4) and/or poor lung function. In case of doubt please contact trial team. 5. Patients with other active malignancy requiring concurrent intervention and/or concurrent treatment with other investigational drugs or anti-cancer therapy 6. Patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period. 7. Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information 8. Patients who have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways 9. Patients with positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection 10. Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) 11. Patients with history of allergy to study drug components excipients 12. Women who are pregnant or in the period of breastfeeding 13. Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study
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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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Complejo Hospitalario Universitario A Coruña
A Coruña, La Coruña, 15006, Spain
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Complejo Hospitalario Universitario de Vigo
Vigo, Pontevedra, 36036, Spain
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Hospital Clínic de Barcelona
Barcelona, Barcelona, 08036, Spain
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Hospital Clínico Lozano Blesa
Zaragoza, Zaragoza, 50009, Spain
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Hospital Clínico San Carlos
Madrid, Madrid, 28040, Spain
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Hospital Clínico Universitario de Valencia
Valencia, Valencia, 46010, Spain
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Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, 47003, Spain
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Hospital Clínico de Salamanca
Salamanca, Salamanca, 37007, Spain
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Hospital Dr. Josep Trueta
Girona, Girona, 17007, Spain
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Hospital General Universitario de Málaga
Málaga, Málaga, 29010, Spain
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Hospital General de Alicante
Alicante, Alicante, 03010, Spain
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Hospital General de Valencia
Valencia, Valencia, 46014, Spain
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Hospital Universitari Dexeus
Barcelona, Barcelona, 08028, Spain
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Hospital Universitari Vall d' Hebron
Barcelona, Barcelona, 08035, Spain
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Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041, Spain
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Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, 28040, Spain
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Hospital Universitario Insular de Gran canaria
Las Palmas de Gran Canaria, Gran Canaria, 35016, Spain
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Hospital Universitario La Paz
Madrid, Madrid, 28046, Spain
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Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222, Spain
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Hospital Universitario Reina Sofía
Córdoba, Córdoba, 14004, Spain
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Hospital Universitario de Cruces
Barakaldo, Vizcaya, 48903, Spain
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Hospital Virgen del Rocío
Seville, Sevilla, 41013, Spain
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Hospital de Sant Pau
Barcelona, Barcelona, 08041, Spain
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ICO Badalona
Badalona, Barcelona, 08916, Spain
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ICO Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
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