Neoplasms

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Carcinoma, Non-Small-Cell Lung

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Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

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Nivolumab

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

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Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

* 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.

* 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)

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.

Carboplatin must be administered at the end of the Paclitaxel infusion

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.

Mariano Provencio, MD

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.

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.

NADIM II: Neo-Adjuvant Immunotherapy

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.

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.

Fundación GECP

The study is based on a blood sample analysis in stage IIIA non-small lung cancer patients that are going to receive neoadjuvant treatment in the real world. The patients participating in this non-interventional study will not receive treatment in relation to the study. Prospective information about treatment after neoadjuvant treatment and after the last blood extraction will not be collected.

Eva Pereira

Maria Saigí, MD

Lucia Teijeira Teijeira, MD

Lucia Teijeira, MD

Joaquín Mosquera, MD

Bartomeu Massuti, MD

Maria González, MD

Alex Martínez, MD

Mª Ángeles Sala, MD

Isidoro Carlos Barneto, MD

Joaquim Bosch, MD

Ana Laura Ortega Granados, MD

Ana Laura Ortega Granados, Md

Natalia Fernández, MD

Carlos Aguado, MD

Jaime Rubio, MD

Javier De Castro, MD

Manuel Cobo, MD

Francisco Javier Garcia, MD

Paloma Martín, MD

Oscar Juan-Vidal, MD

Rafael López, MD

This is an observational, prospective, multicentre and nationwide study.

The study enroll resectable stage IIIA non-small cell lung cancer patients that are going to receive neoadjuvant treatment in real world.

The primary objective of this study is evaluating whether there is a significant association between ctDNA clearance (no detection of ctDNA) after neoadjuvant treatment and before surgery and progression free survival.

This is an observational, multicenter, one-arm, non-comparative, prospective study that will not under any circumstances interfere in the physician's normal clinical practice. Being limited to the collection of blood samples at five times and patient data, it does not entail any diagnostic or therapeutic procedure outside of normal clinical practice.

Approximately 100 resectable stage IIIA non-small cell lung cancer patients that are going to receive neoadjuvant treatment in real world will be recruited for this study in Spain. With this figure, it can be estimated whether ctDNA, both baseline and its negativization, has a role as a prognostic marker in the evolution of these patients in real-life conditions.

The primary objective of this study is evaluate whether there is a significant association between ctDNA clearance (no detection of ctDNA) after neoadjuvant treatment and before surgery and progression free survival.

The study is planned with the recruitment of patients over a year to a follow-up of 36 months post-surgery.

Five blood samples per patient will be collected:

* Before starting neoadjuvant treatment
* At the end of the neoadjuvant treatment and before the surgery
* After surgery
* 6 months after surgery
* At first disease progression (if occurs within 24 months after surgery)

The blood samples (5-10 ml each) will be collected in two Cell-Free DNA BCT tube and two PTT EDTA K2.

These samples will be sent to the central laboratory the same day of extraction at room temperature.

ctDNA will be extracted using the QIAamp Circulating Nucleic Acid Kit. NGS analysis of ctDNA will be performed using a panel that will target at least of 1.5 Mb and will include genes of interest.

Study of ctDNA as Prognostic Factor on Resectable Stage IIIA NSCLC Patients Treated With Neoadjuvant Treatment

To assess the association between the baseline ctDNA and ctDNA clearance with each one of the three outcomes: after neoadjuvant treatment, before surgery and PFS

To assess the association between the baseline ctDNA and ctDNA clearance with each one of the three outcomes: after neoadjuvant treatment, before surgery and Overall Survival

To assess the association between the baseline ctDNA and ctDNA clearance with each one of the two outcomes: after complete response or major pathologic response (MPR).

To identify somatic mutations in ctDNA in the pre-treatment plasma that predispose to a better/worse overall survival.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
NADIM II: Neo-Adjuvant Immunotherapy	NCT03838159	Non Small Cell ...	Paclitaxel Carboplatin Nivolumab	18 Years -	Fundación GECP
Study of ctDNA as Prognostic Factor on Resectable Stage IIIA NSCLC Patients Treated With Neoadjuvant Treatment	NCT05382052	Non Small Cell ... Neoadjuvant Tre...		18 Years -	Fundación GECP
NADIM II: Neo-Adjuvant Immunotherapy	NCT03838159	Non Small Cell ...	Paclitaxel Carboplatin Nivolumab	18 Years -	Fundación GECP

Spots Global Cancer Trial Database for resectable stage iiia