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Non-Small Cell Lung CancerPhase 3NADIM-ADJUVANTNCT04564157

New Adjuvant Trial of Chemotherapy vs Chemo-immunotherapy

A Phase 3 study testing Carboplatin, Paclitaxel and Nivolumab in people with Non-Small Cell Lung Cancer and Adjuvant Chemotherapy, run by Fundación GECP at 30 sites in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is an open-label, randomised, two-arm, phase III, multi-centre clinical trial. 210 stage IB-IIIA, completely resected, non-small cell lung cancer patients will be enrolled in this trial to evaluate the disease free survival between experimental arm (Adjuvant Chemotherapy-Immunotherapy + maintenance adjuvant… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Carboplatin, Paclitaxel and Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
30 sitesSpain
Study dates
13 Jan 2021to 1 Apr 2031
Phase
Phase 3
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

  • 1. Patients diagnosed of primary non-small cell lung cancer, histologically confirmed
  • 2. Patients should be classified postoperatively in stage IB (=4 cm), II or IIIA according to pathological criteria and according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology.
  • 3. Complete surgical resection of the primary NSCLC is also essential. Surgeons are strongly advised to dissect or obtain samples of all accessible lymph node levels, as established in the European Society of Thoracic Surgeons guide . Consequently, at the end of the surgical intervention it is recommended to have obtained samples of a minimum of 3 (three) specific mediastinal ganglionic lobe stations (N2), one of which should include station 7, and at least one N1 station (including those resected with the tumor piece).
  • 4. The surgical intervention may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy, as determined by the responsible surgeon based on intraoperative findings. Patients who have had only segmentectomies or wedge resections are not considered eligible for participation in this study.
  • 5. Preoperative (neoadjuvant) use of platinum-based chemotherapy or other types of chemotherapy are not accepted.
  • 6. Preoperative, postoperative, or scheduled radiation therapy is not accepted for a later time. Patients with only N2 disease, who have to receive post-operative adjuvant radiotherapy will not be eligible.
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  • 7. A minimum of 3 weeks must have elapsed between the surgical intervention performed for the NSCLC and the randomization. Adjuvant treatment must start between the 3rd and the 10th week from surgery.
  • 8. ECOG 0-1
  • 9. Patients aged ≥ 18 years
  • 10. Correct hematological, hepatic and renal function i. Neutrophils ≥ 1500×109/L ii. Platelets ≥ 100 ×109/L iii. Hemoglobin > 9.0 g/dL iv. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min (if using the Cockcroft-Gault).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 x ULN) vii. The patients need to have a forced expiratory volume (FEV1) ≥ 1.2 liters or >40% predicted value viii. INR/APTT within normal limits.
  • 11. Patient consent must be obtained in the appropriate manner as established in the applicable local and regulatory requirements
  • 12. Patients must be accessible for treatment and follow-up
  • 13. 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 3 days before randomization.
  • 14. All sexually active men and women of childbearing potential must use a highly 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 5 months for females and 7 months for males following the last administration of trial drugs.

Who cannot join

  • 1. Patients with a history of other malignant diseases, with the exception of the following:
  • or properly treated non-melanotic skin cancer
  • or cancer in situ treated with curative intent
  • or other malignancies treated with curative intent and without signs of disease for a period of> 3 years after the end of the treatment and which, in the opinion of the doctor in charge of their treatment, do not present a substantial risk of relapse of the previous malignant disease.
  • 2. Patients with ALK, STKB11 o KEAP1 known mutations before inclusion in this trial.
  • 3. Patients with adenocarcinoma NSCLC must be tested for the common EGFR mutations before inclusion. Patients with any known EGFR mutation cannot be enrolled in the study.
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  • 4. Patients with a combination of microcytic and non-small cell lung cancer, a carcinoid lung tumor or large cell neuroendocrine carcinoma.
  • 5. Patients that received live attenuated vaccines within 30 days prior to randomization.
  • 6. History of a primary immunodeficiency, history of organ allogeneic transplantation, use of immunosuppressive drugs within 28 days before randomization or previous history of toxicity of severe immune mechanism (grade 3 or 4) with other immunological treatments
  • 7. Patients with active or uncontrolled infections or with serious medical conditions or disorders that may not allow patient management as established in the protocol
  • 8. Patients who have suffered untreated and / or uncontrolled cardiovascular disorders and / or who have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction in the previous year or ventricular cardiac arrhythmias that require medication, history of atrioventricular conduction of second or third degree). Patients with relevant cardiac history, even when well controlled, should have an LVEF> 50% in the 12 weeks prior to randomization
  • 9. Pregnant or breastfeeding women
  • 10. Patients in whom R0 resection cannot be confirmed
  • 11. Patients with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
  • 12. 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
  • 13. Any positive test result for hepatitis B virus or hepatitis C virus, indicating presence of virus, e.g. Hepatitis B surface antigen (HBsAg, Australia antigen) positive, or Hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative)
  • 14. History of allergy or hypersensitivity to any of the study drug components
  • 15. Prior anti-PD1/L1 treatment

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

Spain30 sites

  • Hospitalario Universitario A Coruña

    A Coruña, La Coruña, 15006

  • Hospital General Universitario de Alicante

    Alicante, Alicante, 03010

  • ICO Badalona, Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Universitario Cruces

    Barakaldo, Vizcaya, 48903

  • Hospital Universitari Quiron Dexeus

    Barcelona, Barcelona, 08028

  • Hospital Universitari Vall d' Hebron

    Barcelona, Barcelona, 08035

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, 08041

  • Hospital Parc Taulí

    Barcelona, Barcelona, 08208

  • Hospital de Basurto

    Bilbao, Bilbao, 48013

  • Hospital San Pedro De Alcántara

    Cáceres, Cáceres, 10003

  • Hospital Universitario Virgen de la Arrixaca

    El Palmar, El Palmar, 30120

  • ICO Girona, Hospital Josep Trueta

    Girona, Girona, 17007

  • Hospital Universitario de Jaén

    Jaén, Jaén, 23007

  • ICO Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitario Insular de Gran canaria

    Las Palmas de Gran Canaria, Gran Canaria, 35016

  • Hospital Universitario Lucus Augusti

    Lugo, Lugo, 27003

  • Hospital Clínico San Carlos

    Madrid, Madrid, 28040

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, Madrid, 28040

  • Hospital Universitario la Paz

    Madrid, Madrid, 28046

  • Hospital Puerta de Hierro

    Madrid, Madrid, 28222

  • Hospital Fundación de Alcorcón

    Madrid, Madrid, 28922

  • Hospital Son Espases

    Palma de Mallorca, Palma de Mallorca, 07120

  • Complejo Hospitalario de Navarra

    Pamplona, Pamplona, 31008

  • Hospital Universitario Nuestra Señora La Candelaria

    Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38009

  • Hospital Virgen del Rocío

    Seville, Sevilla, 41013

  • Instituto Valenciano De Oncología

    Valencia, Valencia, 46009

  • Hospital Clínico de Valencia

    Valencia, Valencia, 46010

  • Hospital General Universitario de Valencia

    Valencia, Valencia, 46014

  • Hospital Universitario La Fe

    Valencia, Valencia, 46026

  • Complexo Hospitalario Universitario De Vigo

    Vigo, Vigo, 36204

Other trials in Spain

About this study

Official title: A Phase III Clinical Trial of Adjuvant Chemotherapy vs Chemoimmunotherapy for Stage IB-IIIA Completely Resected Non-small Cell Lung Cancer (NSCLC) Patients.

This is an open-label, randomised, two-arm, phase III, multi-centre clinical trial.

210 stage IB-IIIA, completely resected, non-small cell lung cancer patients will be enrolled in this trial to evaluate the disease free survival between experimental arm (Adjuvant Chemotherapy-Immunotherapy + maintenance adjuvant Immunotherapy) and control arm (Adjuvant Chemotherapy)

Read the detailed description

This is an open-label, randomised, two-arm, phase III, multicentre clinical trial.The total sample size is 210 and 105 per arm. The population to be included are stage IB-IIIA, completely resected, non-small cell lung cancer patients.

Patients randomised to the experimental arm will receive Nivolumab 360mg + Paclitaxel 200mg/m2 + Carboplatin AUC5 for 4 cycles every 21 days (+/- 3 days) as adjuvant treatment followed by maintenance adjuvant treatment for 6 cycles with Nivolumab 480 mg Q4W (+/- 3 days).

Patients randomized to the control arm will receive Paclitaxel 200mg/m2 + Carboplatin AUC5 for 4 cycles every 21 days (+/- 3 days) followed by 2 observation visits.

The primary objective is to evaluate the disease-free survival (DFS): defined as the length of time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time.

Patient accrual is expected to be completed within 3.5 years, excluding a run-in-period of 3 months. Treatment and follow-up are expected to extend the study duration to a total of 8.5 years. Patients will be followed 5 years after adjuvant treatment or observation phase. The study will end once survival follow-up has concluded.

Keywords
Lung Diseases, Carcinoma, Non-Small-Cell Lung, Stage IB-IIIA lung cancer, Adjuvant treatment, Carcinoma, Bronchogenic, Immunotherapy, Paclitaxel, Carboplatin, Nivolumab, Immune response, Thoracic Neoplasms, Respiratory Tract Neoplasms, Chemotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Diseases, Carcinoma, Bronchogenic, Thoracic Neoplasms, Respiratory Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    Also called Paraplatin

    Structure: The cis-diamino (cyclobutan-1, 1 dicarboxilate) plating. Stability: 24 hours at ambient temperature in 5% glucose, glucosaline or physiologic saline. It is recommended not to dilute with chlorinated solutions for this could affect the carboplatin.

    Route of administration: Intravenous infusion.

    Guidelines of Carboplatin administration: According to the standard of each center.

  • PaclitaxelDrug

    Also called Taxol

    Structure: A diterpene whose composition is: 5b, 20-epoxy-1, 2a, 4,7b, 10b, 13a-hexa-hidroxytax-11-en 9 one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)- N-benzoyl-3-phenylisoserine.

    Stability: Concentrations of 0.3-1.2 mg/ml in 5% dextrose or normal saline have demonstrated chemical and physical stability for more that 27 hours at ambient temperature (25ºC approximately). The intact vial must be stored between 15º and 25ºC.

    Guidelines on Paclitaxel administration: Paclitaxel must be administered by infusion over 3 hours in dextrose (D5W) or normal saline (NS). The concentration must not exceed 1.2 mg/ml.

  • NivolumabDrug

    Also called Opdivo

    Structure: Nivolumab is a soluble protein consisting of 4 polypeptide chains.

    Route of administration: Intravenous infusion.

    Product Description: Nivolumab (BMS-936558-01) Injection drug product is a sterile, non-pyrogenic, single-use, isotonic aqueous solution formulated in 10 mg/ml.

    Storage Conditions: It must be stored at 2 to 8 degrees Cº and protected from light and freezing.

    Guidelines: The administration of nivolumab infusion must be completed within 24 hours of preparation.The dose of Nivolumab for the adjuvant treatment is 360 mg administered as an intravenous infusion over 30 minutes every 3 weeks (+/-3 days) for 4 cycles.

    For the maintenance adjuvant treatment the dose is nivolumab 480 mg Q4W (+/-3 days) over 30 minutes for 6 months (6 cycles).

    Subjects should be carefully monitored during nivolumab administration to follow infusion reactions.

    Doses of nivolumab may be interrupted, delayed, or discontinued depending on how well the subject tolerates the treatment.

Study groups in NCT04564157
Study groupRoleWhat they receive
Adjuvant treatment + Adjuvant maintenance treatmentExperimentalAdjuvant treatment: * Paclitaxel: 200mg/m2 infusion over 3 hours * Carboplatin: AUC5 at the end of the Paclitaxel infusion * Nivolumab: 360 mg intravenous Q3W It has to start within 3-10 weeks from surgery and the first administration has to be done within 1-3 days from randomization. 4 cycles will be administered at 21day intervals (QW3) after surgery. A CT-SAN must be done after the 4 cycles of adjuvant treatment. Patients must discontinue treatment if there is evidence of disease relapse. After the 4 cycles of chemo-immunotherapy the patient will receive: Adjuvant maintenance treatment: Nivolumab: 480 mg IV Q4W It will start after 4 weeks from day 1 cycle 4 of adjuvant treatment. 6 cycles will be administered every 28 days. A CT-SAN must be done within +/- 7 days from day 28 of the 3rd cycle of adjuvant maintenance treatment and within +/- 7 days at the end of the 6th cycle. Patients must discontinue treatment if there is evidence of disease relapse at 3rd cycle CT-SCAN.
Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Nivolumab
Control arm: Adjuvant treatmentActive comparatorAdjuvant treatment: * Paclitaxel: 200mg/m2 infusion over 3 hours * Carboplatin: AUC5 at the end of the Paclitaxel infusion Adjuvant treatment has to start within 3-10 weeks from surgery and the first administration and has to be done within 1-3 days from randomization. 4 cycles will be administered at 21-day (+/- 3 days) intervals (QW3) after surgery. A CT-SAN must be done after the 4 cycles of adjuvant treatment. Observation: 2 observation visits will be done at 3 months and at 6 months from day 21 of cycle 4 of adjuvant treatment.
Receives: Drug: Carboplatin; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The disease-free survival

    The length of time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time.

    Measured: From the date of randomization to the date of last follow up, assessed up to 60 months

Secondary outcomes (2)

  1. Overall survival

    Defined as the time between the date of randomization and the date of death

    Measured: From the date of randomization until the date of last follow up, assessed up to 60 months

  2. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

    It will be measured by the incidence of AE, SAE, immune-related AEs, deaths, and laboratory abnormalities. Adverse events will be graded according to CTCAE v5.0

    Measured: From the subject's written consent to participate in the study through 100 days after the final administration of the drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2020
  2. Study start13 Jan 2021
  3. Primary completion1 Apr 2030 (estimated)
  4. Study completion1 Apr 2031 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Design: Open-label, randomised, two arm, phase III, multicentre clinical trial
Masking
None (open label)
Enrolment
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04564157
Sponsor's protocol ID
GECP 20/05_NADIM-ADJUVANT
Other IDs
2020-002088-71
Acronym
NADIM-ADJUVANT
Status last verified
Apr 2026
First submitted
21 Sep 2020
Last updated
5 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Carboplatin, Paclitaxel and Nivolumab in people with Non-Small Cell Lung Cancer and Adjuvant Chemotherapy, run by Fundación GECP at 30 sites in Spain.

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 14 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

The disease-free survival (time frame: From the date of randomization to the date of last follow up, assessed up to 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04564157.

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 5 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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