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Non Small Cell Lung CancerPhase 2NADIMIINCT03838159

NADIM II: Neo-Adjuvant Immunotherapy

A Phase 2 study testing Paclitaxel, Carboplatin and Nivolumab in people with Non Small Cell Lung Cancer, run by Fundación GECP at 25 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 II, multi-centre clinical trial. 90 patients will be enrolled in this trial to examine the pathological Complete Response defined as the absence of residual tumor in lung and lymph nodes comparing patients treated with chemo-immunotherapy versus chemotherapy alone. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Paclitaxel, Carboplatin and Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
25 sitesSpain
Study dates
15 May 2019to 30 Nov 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
  • Tumor should be considered resectable before study entry by a multidisciplinary team
  • ECOG (Performance status) 0-1
  • Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to randomization.
  • 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
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  • 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
  • Patients aged > 18 years
  • 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.
  • 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
  • Patient capable of proper therapeutic compliance and accessible for correct follow-up
  • Measurable or evaluable disease (according to RECIST 1.1 criteria)

Who cannot join

  • All patients carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene.
  • 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.
  • 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.
  • 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.
  • Patients with other active malignancy requiring concurrent intervention and/or concurrent treatment with other investigational drugs or anti-cancer therapy
  • 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.
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  • 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
  • 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
  • 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
  • Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • Patients with history of allergy to study drug components excipients
  • Women who are pregnant or in the period of breastfeeding
  • Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

Spain25 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, La Coruña, 15006

  • Hospital General de Alicante

    Alicante, Alicante, 03010

  • ICO Badalona

    Badalona, Barcelona, 08916

  • Hospital Universitario de Cruces

    Barakaldo, Vizcaya, 48903

  • Hospital Universitari Dexeus

    Barcelona, Barcelona, 08028

  • Hospital Universitari Vall d' Hebron

    Barcelona, Barcelona, 08035

  • Hospital Clínic de Barcelona

    Barcelona, Barcelona, 08036

  • Hospital de Sant Pau

    Barcelona, Barcelona, 08041

  • Hospital Universitario Reina Sofía

    Córdoba, Córdoba, 14004

  • Hospital Dr. Josep Trueta

    Girona, Girona, 17007

  • ICO Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitario Insular de Gran canaria

    Las Palmas de Gran Canaria, Gran Canaria, 35016

  • Hospital Clínico San Carlos

    Madrid, Madrid, 28040

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Hospital General Universitario de Málaga

    Málaga, Málaga, 29010

  • Hospital Clínico de Salamanca

    Salamanca, Salamanca, 37007

  • Hospital Virgen del Rocío

    Seville, Sevilla, 41013

  • Hospital Clínico Universitario de Valencia

    Valencia, Valencia, 46010

  • Hospital General de Valencia

    Valencia, Valencia, 46014

  • Hospital Clínico Universitario de Valladolid

    Valladolid, Valladolid, 47003

  • Complejo Hospitalario Universitario de Vigo

    Vigo, Pontevedra, 36036

  • Hospital Clínico Lozano Blesa

    Zaragoza, Zaragoza, 50009

Other trials in Spain

About this study

Official title: A Randomized Phase II Study of Neo-adjuvant Chemo/Immunotherapy Versus Chemotherapy Alone for the Treatment of Locally Advanced and Potentially Resectable Non-small Cell Lung Cancer (NSCLC) Patients.

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

90 patients will be enrolled in this trial to examine the pathological Complete Response defined as the absence of residual tumor in lung and lymph nodes comparing patients treated with chemo-immunotherapy versus chemotherapy alone.

Read the detailed description

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

Patients randomised to the experimental arm will receive Nivolumab 360mg + Paclitaxel 200mg/m2 + Carboplatin AUC5 for 3 cycles every 21 days as neoadjuvant treatment followed by surgery and 6 months of adjuvant treatment with Nivolumab 480 mg Q4W. Patients randomized to the control arm will receive Paclitaxel 200mg/m2 + Carboplatin AUC5 for 3 cycles every 21 days followed by surgery.

The primary objective is pathological Complete Response (pCR) defined as the absence of residual tumor in lung and lymph nodes comparing patients treated with chemo-immunotherapy versus chemotherapy alone.

Patient accrual is expected to be completed within 3 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 surgery. The study will end once survival follow-up has concluded.

Keywords
Inmunotherapy, Resectable stage IIIA, Adjuvant treatment
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • PaclitaxelDrug

    Also called Taxol

    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.

    The infusions must be mixed as soon as possible before the start of each infusion since the stability of paclitaxel beyond 24 hours is not known.

    In-line filtration is obligatory since a small number of fibers within the acceptable limits of the USP Particulate Matter Test for LVP have been reported. Cellulose acetate filters of 0.22-micron pore size (such as IVEX II) can be used. The solution that shows excessive particulate matter must be rejected.

  • CarboplatinDrug

    Also called Paraplatin

    Carboplatin must be administered at the end of the Paclitaxel infusion

  • NivolumabDrug

    Also called Opdivo

    Nivolumab is a soluble protein consisting of 4 polypeptide chains, which include 2 identical heavy chains and 2 identical light chains.

    The administration of nivolumab infusion must be completed within 24 hours of preparation.

Study groups in NCT03838159
Study groupRoleWhat they receive
Experimental: Neo-Adjuvant ImmunotherapyExperimental* Neoadjuvant treatment (200 mg/m3 Paclitaxel+ AUC5 Carboplatin+ 360 mg Nivolumab) will start within 1-3 days from randomisation. 3 cycles will be administered at 21-day (+/- 3 days) intervals (QW3) prior to surgery. Before surgery a tumor assessment will be done. Patients must leave the study if there is evidence of progression. Patients with stable disease or partial response may be considered for surgery. * Surgery: Surgery must be done within the 3rd-4th week (+7 days) from day 21 cycle 3 of neoadjuvant treatment (day 42-49 after day 1 of cycle 3) . * Adjuvant treatment:Nivolumab: 480 mg Q4W (+/- 3 days) for 6 months (6 cycles). Patients that are R0 confirmed by surgical pathology evaluation will receive the first adjuvant administration within the 3rd to 8th week (+ 7 days) from surgery and for 6 months.
Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: Nivolumab
Control: Neo-Adjuvant ChemotherapyActive comparator* Neoadjuvant treatment (200mg/m3 Paclitaxel+ AUC5 Carboplatin). It will start within 1-3 days from randomisation. 3 cycles will be administered at 21-day (+/- 3 days) intervals (QW3) prior to surgery. Before surgery a tumor assessment will be done. Patients must leave the study if there is evidence of progression. Patients with stable disease or partial response may be considered for surgery. * Surgery: Surgery must be done within the 3rd-4th week (+7 days) from day 21 cycle 3 of neoadjuvant treatment (day 42-49 after day 1 of cycle 3)
Receives: Drug: Paclitaxel; Drug: Carboplatin

What is being measured

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

  1. Evaluation of the pathological complete response (pCR)

    The pathological complete response is defined as the absence of residual tumor in lung and lymph nodes in patients treated with chemo-immunotherapy versus patients treated with chemotherapy alone.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 45 months.

Timeline

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

  1. First posted12 Feb 2019
  2. Study start15 May 2019
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion30 Nov 2028 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03838159
Sponsor's protocol ID
GECP 18/02_NADIM II
Other IDs
2018-004515-45, 2018
Acronym
NADIMII
Status last verified
Apr 2026
First submitted
8 Feb 2019
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sierra-Rodero B, Gil-Gonzalez A, Molina-Alejandre M, Nadal E, Calvo V, Lazaro M, Insa A, Massuti B, Martinez Marti A, de Castro J, Garcia Campelo R, Gonzalez Larriba JL, Bernabe R, Domine M, Ponce Aix S, Cobo M, Camps C, Reguart N, Bosch-Barrera J, Majem M, Aguilar A, Palmero R, Blanco Clemente M, Martin-Lopez J, Munoz-Viana R, Megias D, Gutierrez-Escobedo JM, Martinez-Toledo C, Cruz-Bermudez A, Provencio M. Decoding B-cell Signatures of Complete Pathologic Response to Perioperative Chemoimmunotherapy in Non-Small Cell Lung Cancer. Clin Cancer Res. 2026 Apr 15;32(8):1499-1512. doi: 10.1158/1078-0432.CCR-25-3315.

    PubMed 41805895

  • Provencio M, Nadal E, Gonzalez-Larriba JL, Martinez-Marti A, Bernabe R, Bosch-Barrera J, Casal-Rubio J, Calvo V, Insa A, Ponce S, Reguart N, de Castro J, Mosquera J, Cobo M, Aguilar A, Lopez Vivanco G, Camps C, Lopez-Castro R, Moran T, Barneto I, Rodriguez-Abreu D, Serna-Blasco R, Benitez R, Aguado de la Rosa C, Palmero R, Hernando-Trancho F, Martin-Lopez J, Cruz-Bermudez A, Massuti B, Romero A. Perioperative Nivolumab and Chemotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Aug 10;389(6):504-513. doi: 10.1056/NEJMoa2215530. Epub 2023 Jun 28.

    PubMed 37379158

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel, Carboplatin and Nivolumab in people with Non Small Cell Lung Cancer, run by Fundación GECP at 25 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 12 inclusion and 13 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 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 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 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?

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?

Evaluation of the pathological complete response (pCR) (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 45 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 NCT03838159, which also lists 2 linked publications.

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 30 Apr 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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