Lung DiseasesPhase 2APOLONCT04776447
Atezolizumab Plus Induction Chemotherapy Plus CT-radiotherapy. (APOLO)
A Phase 2 study testing Carboplatin, Placlitaxel and Atezolizumab in people with Lung Diseases and Carcinoma, Non-Small-Cell Lung, run by Fundación GECP at 22 sites in Spain.
Trial summary
Open-label, non-randomized, phase II multi-centre controlled clinical trial. 51 non-resectable stage IIIA-IIIB non-small cell lung cancer patients will be enrolled in this trial to evaluate the efficacy of the treatment (Atezolizumab + Induction chemotherapy (CT) + CT-Radiotherapy) in terms of the Progression Free… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Diseases, Carcinoma, Non-Small-Cell Lung, Stage IIIA Non-small Cell Lung Cancer
- What is being tested?
- Carboplatin, Placlitaxel and Atezolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 22 sitesSpain
- Study dates
- 16 Jun 2021to 31 Jul 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged ≥ 18 years old and ≤ 75 years.
- ECOG Scale (Eastern Cooperative Oncology Group) of performance status of 0 or 1.
- Histologically or cytologically confirmed, non-resectable Stage IIIA-IIIB NSCLC according to the 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology.
- PET-CT (Positron Emission Tomography -Computed tomography) and brain computed tomography or Magnetic resonance imaging (MRI) at baseline to confirm the absence of distant disease.
- Mediastinal involvement could be considered without histological confirmation when no margin can be distinguished in the lymph node mass.
- No prior treatment with anti-neoplastic drugs or thoracic radiotherapy for Stage IIIA-IIIB NSCLC.
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- Patients who have received prior neo-adjuvant, adjuvant chemotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from enrollment since the last chemotherapy.
- Presence of at least one measurable disease by CT-SCAN, as defined by RECIST v1.1.
- Adequate hematologic and organ function defined by the following laboratory results obtained within 14 days prior to enrollment:
- Neutrophils ≥ 1500 cells/μL without granulocyte colony-stimulating factor support.
- Lymphocyte count ≥ 500/μL.
- Platelet count ≥ 100,000/μL without transfusion.
- Haemoglobin ≥ 10.0 g/dL. Patients may be transfused to meet this criterion.
- INR or aPTT ≤ 1.5 × upper limit of normal (ULN). This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.
- AST, ALT, and alkaline phosphatase ≤ 2.5 × ULN, with the following exceptions:
- Serum bilirubin ≤ 1.5 × ULN. Patients with known Gilbert disease who have serum bilirubin level ≤ 3 × ULN may be enrolled.
- Serum creatinine ≤ 1.5 × ULN or creatinine clearance of ≥60ml/min (based on the Cockcroft Gault formula).
- 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.
- Adequate lung function: Forced Expiratory Volumen in 1 second (FEV1) >50% of normal volume and Diffusion Capacity of the Lungs for Carbon Monoxide (DLCO) >40% of normal value.
- No more than 35% of the total volume of the two lungs should receive more than 20 Gy (V20) or no more than 7cm maximum diameter.
- For female patients of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception that results in a low failure rate (< 1% per year) when used consistently and correctly, and to continue its use for 6 months after the last dose of trial treatment. Such methods include: combined (oestrogen and progesterone containing) hormonal contraception, progestogen-only hormonal contraception associated with inhibition of ovulation together with another additional barrier method always containing a spermicide, intrauterine device (IUD): intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner (on the understanding that this is the only one partner during the whole study duration), and sexual abstinence.
- For male patients with female partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception that results in a low failure rate [< 1% per year] when used consistently and correctly, and to continue its use for 6 months after the last dose of trial treatment. Male patients should not donate sperm during this study and for at least 6 months after the last dose of trial treatment.
- Oral contraception should always be combined with an additional contraceptive method because of a potential interaction with the study drugs. The same rules are valid for male patients involved in this clinical study if they have a partner of childbirth potential. Male patients must always use a condom.
- Women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 8 days prior to initiation of study drug.
Who cannot join
- Patients with known sensitizing mutation or an amplification in the epidermal growth factor receptor (EGFR) gene, ALK fusion oncogene.
- Known STK-11 ligand alterations, MDM2 amplifications or ROS1 translocations.
- Weight loss >10% within the previous 3 months.
- Malignant pleural effusion or pericardial effusion: both will be considered as suggestive of metastatic disease. Also excluded those with negative cytology but being exudates.
- Patients with non-visible by thoracic X-Ray pleural effusion or too small to be safely punctioned could be included.
- Malignancies other than NSCLC within 3 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death (e.g., expected 3-year OS > 90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous-cell skin cancer, localized prostate cancer treated with radiotherapy or surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent).
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- Women who are pregnant, lactating, or intending to become pregnant during the study.
- Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the Atezolizumab formulation.
- History of autoimmune disease.
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- Positive test for human immunodeficiency viruses (HIV). All patients will be tested for HIV prior to inclusion into the study; patients who test positive for HIV will be excluded from the clinical study.
- Patients with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C.
- Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of HBsAg) are eligible only if they are negative for HBV DNA (vaccinated patients are excluded).
- Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA.
- Active tuberculosis.
- Symptomatic neuropathy (sensory) grade > 1 according to the NCI Common Toxicity Criteria for Adverse Events v5.0
- Severe infections within 4 weeks prior to be included in the study, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.
- Received therapeutic oral or IV antibiotics within 2 weeks prior to be included in the study.
- Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or to prevent chronic obstructive pulmonary disease exacerbation) are eligible.
- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to inclusion, unstable arrhythmias, or unstable angina.
- Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction < 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate.
- Patients with a superior vena cava syndrome.
- Major surgical procedure other than for diagnosis within 28 days prior to inclusion or anticipation of need for a major surgical procedure during the course of the study.
- Prior allogeneic bone marrow transplantation or solid organ transplant.
- Administration of a live, attenuated vaccine within 4 weeks before inclusion or anticipation that such a live attenuated vaccine will be required during the study.
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications.
- Patients with illnesses or conditions that interfere with their capacity to understand follow and/or comply with study procedures.
- Treatment with any other investigational agent with therapeutic intent within 28 days prior to initiation of study treatment.
- Treatment with systemic immunosuppressive medications (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to inclusion.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Spain22 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 de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08041
Hospital Parc Taulí
Barcelona, Barcelona, 08208
Hospital de Basurto
Bilbao, Bilbao, 48013
Hospital General Universitario de Elche
Elche, Alicante, 03203
ICO Girona, Hospital Josep Trueta
Girona, Girona, 17007
Hospital Universitario de Jaén
Jaén, Jaén, 23007
Hospital Universitario Insular de Gran canaria
Las Palmas de Gran Canaria, Gran Canaria, 35016
Hospital Universitario Severo Ochoa
Leganés, Madrid, 28911
Hospital Universitario Lucus Augusti
Lugo, Lugo, 27003
Hospital Universitario Infanta Leonor
Madrid, Madrid, 28031
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, 28040
Hospital Universitario HM Sanchinarro
Madrid, Madrid, 28050
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Hospital Santa María Nai
Ourense, Ourense, 32005
Hospital Son Espases
Palma de Mallorca, Palma de Mallorca, 07120
Hospital Clínico de Valencia
Valencia, Valencia, 46010
Hospital General Universitario de Valencia
Valencia, Valencia, 46014
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, 47003
About this study
Official title: A Phase II Trial of Atezolizumab Plus Induction Chemotherapy (CT) Plus Chemo-radiotherapy and Atezolizumab Maintenance Therapy in Non-resectable Stage IIIA-IIIB Non-small Cell Lung Cancer (NSCLC) Patients
Open-label, non-randomized, phase II multi-centre controlled clinical trial.
51 non-resectable stage IIIA-IIIB non-small cell lung cancer patients will be enrolled in this trial to evaluate the efficacy of the treatment (Atezolizumab + Induction chemotherapy (CT) + CT-Radiotherapy) in terms of the Progression Free Survival at 12 months
Read the detailed description
This is an open-label, non-randomized, phase II multi-centre controlled clinical trial.The total sample size is 51 patients. The population to be included are non-resectable stage IIIA-IIIB non-small cell lung cancer patients.
Patients randomised will receive induction treatment (Atezolizumab 1200mg+ Carboplatin AUC5+Paclitaxel 200 mg/m2 for 3 cycles) and concurrent chemotherapy (CT) -radiotherapy treatment for 3 cycles. At the end of concurrent treatment Atezolizumab 1200mg maintenance treatment will start and will be administered for 12 months (16 cycles).
The primary objective is to assess the efficacy of the treatment (Atezolizumab + Induction chemotherapy (CT) + CT-Radiotherapy) in terms of the Progression Free Survival (PFS) at 12 months according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
PFS are defined as the time from inclusion until objective tumor progression or death.
Patient accrual is expected to be completed within 2 years, treatment is planned to extend during 1.5 years and the patients will be followed up for 2 years. The study will end once survival follow-up has concluded.
- Conditions
- Lung Diseases, Carcinoma, Non-Small-Cell Lung, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Respiratory Tract Neoplasms, Carcinoma Bronchiogenic Stage III
- Being tested
- Carboplatin, Placlitaxel, Atezolizumab
- Keywords
- Chemo-radiotherapy, Immunotherapy, Atezolizumab, Carboplatin, Paclitaxel, Induction chemotherapy, Maintenance treatment, ctDNA levels, Antineoplastic Agents, Induction chemo-immunotherapy, Non-resectable non-small cell lung cancer
- Medical subject headings
- Lung Diseases, Carcinoma, Non-Small-Cell Lung, Respiratory Tract Neoplasms, Carcinoma, Bronchogenic, Thoracic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
Also called Carboplatinum
Structure: The cis-diamino (cyclobutane-1, 1 dicarboxylate) plating. Stability: 24 hours at ambient temperature in 5% glucose, glucosamine 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.
Other Name: ATC code: L01XA02
PlaclitaxelDrug
Also called Taxol
Structure: A diterpene whose composition is: 5b, 20-epoxy-1, 2a, 4,7b, 10b, 13a-hexahidroxytax-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 than 27 hours at ambient temperature (25ºC approximately). The intact vial must be stored between 15º and 25ºC.
Guidelines of 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.
AtezolizumabDrug
Also called Tecentriq
Atezolizumab is a humanized immunoglobulin (IgG1) monoclonal antibody that is produced in Chinese hamster ovary (CHO) cells. Atezolizumab targets programmed death-ligand 1 (PD-L1) on tumor-infiltrating immune cells (ICs) or tumor cells (TCs) and prevents interaction with the programmed death-1 (PD-1) receptor and B7.1 (CD80), both of which function as inhibitory receptors expressed on T cells and other immune cells.
Patients will receive 1200 mg of atezolizumab administered by IV infusion every 21 days (+/- 3 days) in a monitored setting where there is immediate access to trained personnel and adequate equipment/medicine to manage potentially serious reactions.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Atezolizumab plus induction chemotherapy plus CT-radiotherapy | Experimental | Induction Treatment:
Atezolizumab: 1200mg, IV infusion Carboplatin: AUC5, IV infusion Paclitaxel: 200 mg/m2 The treatment will start within 1-5 days from enrollment. The treatment will be 3 cycles administered at 21-day intervals.
Concurrent Chemotherapy (CT)-Radiotherapy Treatment:
Chemotherapy and radiotherapy treatment will be at the discretion of the principal investigator of each site. It is recommended to use as concurrent chemotherapy treatment a platinum based doublet.
After the 3rd cycle of the induction treatment, concurrent treatment will start, 1st concurrent cycle will be administered from day 1 of cycle 3 of induction treatment.
Concurrent chest radiotherapy will be administered starting at day 1 of cycle 1 of concurrent chemo-radiotherapy.
Maintenance with Atezolizumab:
Atezolizumab: 1200mg, IV infusion After the 3rd cycle of the concurrent treatment, Atezolizumab maintenance treatment will start from day 1 of cycle 6 and will be administered for 12 months. Receives: Drug: Carboplatin; Drug: Placlitaxel; Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Assess the Efficacy of the Treatment in Terms of the Progression Free Survival (PFS) at 12 Months
To assess the efficacy of the treatment (Atezolizumab + Induction chemotherapy (CT) + CT-Radiotherapy) in terms of the Progression Free Survival (PFS) at 12 months according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.PFS is defined as the time from inclusion until objective tumor progression or death.
The efficacy at 12 months is calculated as the percentage of patients who have not shown disease progression during the first 12 months.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: From the date of treatment discontinuation, which may occur during any treatment phase, up to 12 months post-discontinuation.
Secondary outcomes (2)
To Evaluate the Overall Response Rate (ORR) of the Treatment
To evaluate the ORR of the treatment as measured by investigator-assessed overall response rate (ORR) according to RECIST v1.1.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Measured: From the date of randomization to the date of last follow up, assessed up to 36 months
To Evaluate the Overall Survival (OS) Rate
To evaluate the Overall survival (OS) rate at 12 and 24 months of the treatment.
Measured: From the date of treatment discontinuation, which may occur during any treatment phase, up to 12 months post-discontinuation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start16 Jun 2021
- Primary completion15 Jan 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- Design: Open-label, non-randomized, phase II multi-centre controlled clinical trial.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación GECP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariano Provencio, MD, Study chair, Fundación GECP President
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776447
- Sponsor's protocol ID
- GECP 20/08_APOLO
- Other IDs
- 2020-004459-33
- Acronym
- APOLO
- Status last verified
- Jul 2026
- First submitted
- 24 Feb 2021
- Last updated
- 22 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Atezolizumab Plus Induction Chemotherapy (CT) Plus Chemo-radiotherapy and Atezolizumab Maintenance Therapy in Non-resectable Stage IIIA-IIIB Non-small Cell Lung Cancer (NSCLC) Patients
- ClinicalTrials.gov ID
- NCT04776447
- Acronym / sponsor ID
- APOLO / GECP 20/08_APOLO
- Conditions
- Lung Diseases, Carcinoma, Non-Small-Cell Lung, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Respiratory Tract Neoplasms, Carcinoma Bronchiogenic Stage III
- Keywords
- Chemo-radiotherapy, Immunotherapy, Atezolizumab, Carboplatin, Paclitaxel, Induction chemotherapy, Maintenance treatment, ctDNA levels
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Fundación GECPUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Posted 22 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label, non-randomized, phase II multi-centre controlled clinical trial.
51 non-resectable stage IIIA-IIIB non-small cell lung cancer patients will be enrolled in this trial to evaluate the efficacy of the treatment (Atezolizumab + Induction chemotherapy (CT) + CT-Radiotherapy) in terms of the Progression Free Survival at 12 months
Detailed description
This is an open-label, non-randomized, phase II multi-centre controlled clinical trial.The total sample size is 51 patients. The population to be included are non-resectable stage IIIA-IIIB non-small cell lung cancer patients.
Patients randomised will receive induction treatment (Atezolizumab 1200mg+ Carboplatin AUC5+Paclitaxel 200 mg/m2 for 3 cycles) and concurrent chemotherapy (CT) -radiotherapy treatment for 3 cycles. At the end of concurrent treatment Atezolizumab 1200mg maintenance treatment will start and will be administered for 12 months (16 cycles).
The primary objective is to assess the efficacy of the treatment (Atezolizumab + Induction chemotherapy (CT) + CT-Radiotherapy) in terms of the Progression Free Survival (PFS) at 12 months according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
PFS are defined as the time from inclusion until objective tumor progression or death.
Patient accrual is expected to be completed within 2 years, treatment is planned to extend during 1.5 years and the patients will be followed up for 2 years. The study will end once survival follow-up has concluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Design: Open-label, non-randomized, phase II multi-centre controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Atezolizumab plus induction chemotherapy plus CT-radiotherapy | Experimental | Drug: Carboplatin, Drug: Placlitaxel, Drug: AtezolizumabInduction Treatment: Atezolizumab: 1200mg, IV infusion Carboplatin: AUC5, IV infusion Paclitaxel: 200 mg/m2 The treatment will start within 1-5 days from enrollment. The treatment will be 3 cycles administered at 21-day intervals. Concurrent Chemotherapy (CT)-Radiotherapy Treatment: Chemotherapy and radiotherapy treatment will be at the discretion of the principal investigator of each site. It is recommended to use as concurrent chemotherapy treatment a platinum based doublet. After the 3rd cycle of the induction treatment, concurrent treatment will start, 1st concurrent cycle will be administered from day 1 of cycle 3 of induction treatment. Concurrent chest radiotherapy will be administered starting at day 1 of cycle 1 of concurrent chemo-radiotherapy. Maintenance with Atezolizumab: Atezolizumab: 1200mg, IV infusion After the 3rd cycle of the concurrent treatment, Atezolizumab maintenance treatment will start from day 1 of cycle 6 and will be administered for 12 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Male or female, aged ≥ 18 years old and ≤ 75 years.
- ECOG Scale (Eastern Cooperative Oncology Group) of performance status of 0 or 1.
- Histologically or cytologically confirmed, non-resectable Stage IIIA-IIIB NSCLC according to the 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology.
- PET-CT (Positron Emission Tomography -Computed tomography) and brain computed tomography or Magnetic resonance imaging (MRI) at baseline to confirm the absence of distant disease.
- Mediastinal involvement could be considered without histological confirmation when no margin can be distinguished in the lymph node mass.
Key exclusion criteria (29 listed)
- Patients with known sensitizing mutation or an amplification in the epidermal growth factor receptor (EGFR) gene, ALK fusion oncogene.
- Known STK-11 ligand alterations, MDM2 amplifications or ROS1 translocations.
- Weight loss >10% within the previous 3 months.
- Malignant pleural effusion or pericardial effusion: both will be considered as suggestive of metastatic disease. Also excluded those with negative cytology but being exudates.
- Patients with non-visible by thoracic X-Ray pleural effusion or too small to be safely punctioned could be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarboplatinAlso: CarboplatinumStructure: The cis-diamino (cyclobutane-1, 1 dicarboxylate) plating. Stability: 24 hours at ambient temperature in 5% glucose, glucosamine 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. Other Name: ATC code: L01XA02 | Drug | Experimental: Atezolizumab plus induction chemotherapy plus CT-radiotherapy |
| PlaclitaxelAlso: TaxolStructure: A diterpene whose composition is: 5b, 20-epoxy-1, 2a, 4,7b, 10b, 13a-hexahidroxytax-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 than 27 hours at ambient temperature (25ºC approximately). The intact vial must be stored between 15º and 25ºC. Guidelines of 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. | Drug | Experimental: Atezolizumab plus induction chemotherapy plus CT-radiotherapy |
| AtezolizumabAlso: TecentriqAtezolizumab is a humanized immunoglobulin (IgG1) monoclonal antibody that is produced in Chinese hamster ovary (CHO) cells. Atezolizumab targets programmed death-ligand 1 (PD-L1) on tumor-infiltrating immune cells (ICs) or tumor cells (TCs) and prevents interaction with the programmed death-1 (PD-1) receptor and B7.1 (CD80), both of which function as inhibitory receptors expressed on T cells and other immune cells. Patients will receive 1200 mg of atezolizumab administered by IV infusion every 21 days (+/- 3 days) in a monitored setting where there is immediate access to trained personnel and adequate equipment/medicine to manage potentially serious reactions. | Drug | Experimental: Atezolizumab plus induction chemotherapy plus CT-radiotherapy |
Primary outcome
To Assess the Efficacy of the Treatment in Terms of the Progression Free Survival (PFS) at 12 Months
Time frame: From the date of treatment discontinuation, which may occur during any treatment phase, up to 12 months post-discontinuation.
To assess the efficacy of the treatment (Atezolizumab + Induction chemotherapy (CT) + CT-Radiotherapy) in terms of the Progression Free Survival (PFS) at 12 months according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.PFS is defined as the time from inclusion until objective tumor progression or death. The efficacy at 12 months is calculated as the percentage of patients who have not shown disease progression during the first 12 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
2 secondary outcomes
To Evaluate the Overall Response Rate (ORR) of the Treatment
Time frame: From the date of randomization to the date of last follow up, assessed up to 36 months
To Evaluate the Overall Survival (OS) Rate
Time frame: From the date of treatment discontinuation, which may occur during any treatment phase, up to 12 months post-discontinuation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Web page of the sponsor where users can find more information about Fundación GECP studiesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariano Provencio, MD study chair
Fundación GECP President
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carboplatin, Placlitaxel and Atezolizumab in people with Lung Diseases and Carcinoma, Non-Small-Cell Lung, run by Fundación GECP at 22 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 24 inclusion and 29 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: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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?
Yes. Results are posted in the registry (first posted 22 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Assess the Efficacy of the Treatment in Terms of the Progression Free Survival (PFS) at 12 Months (time frame: From the date of treatment discontinuation, which may occur during any treatment phase, up to 12 months post-discontinuation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2026.