Lung Cancer, Nonsmall CellPhase 2NCT06667154
Efficacy Analysis of Neoadjuvant Treatment in Lung Cancer Using Low-dose Nivolumab Combined With Chemotherapy
A Phase 2 study testing Low-dose nivolumab combined with platinum-based doublet chemotherapy in people with Lung Cancer, Nonsmall Cell and Non-Small Cell Lung Cancer NSCLC, run by Aline Fusco Fares, MD at 1 site in Brazil.
Trial summary
The primary objective of this study is to assess the major pathological response (MPR) rate and pathologic complete response (pCR) rate in stage IB-IIIA non-small cell lung cancer (NSCLC) treated with a low dose of neoadjuvant immunotherapy combined with platinum doublet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Nonsmall Cell, Non-Small Cell Lung Cancer NSCLC
- What is being tested?
- Low-dose nivolumab combined with platinum-based doublet chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Oct 2023to 31 Oct 2027
- 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
- Able to provide a signed Informed Consent Form (ICF), indicating agreement to comply with the requirements and restrictions in the ICF and protocol.
- Male or female, aged 18 years or older.
- Diagnosed with non-small cell lung cancer (NSCLC) with clinical staging IB, II, or IIIA.
- Receiving treatment at Hospital de Base.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment, with no decline from two weeks prior to the baseline period or the day of the first dose.
- Tumor sample meets the following requirements:
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- Negative for EGFR gene expression.
- Negative for ALK and ROS1 protein expression.
- PD-L1 protein expression documented and assessable.
- Tumor is considered resectable upon initial assessment by three thoracic oncology surgeons (IR, CM, and HN) following a multidisciplinary review.
- Adequate organ and bone marrow function as defined below:
- Hemoglobin: ≥ 9.0 g/dL*
- Absolute neutrophil count: ≥ 1.5 × 10^9 /L*
- Platelet count: ≥ 100 × 10^9 /L*
- *Note: Granulocyte colony-stimulating factor (G-CSF), platelet transfusions, and blood transfusions are not permitted to meet these values.
- Serum bilirubin: ≤ 1.5 × upper limit of normal (ULN), except for participants with confirmed Gilbert syndrome, who may be included upon physician consultation.
- ALT and AST: ≤ 2.5 × ULN.
- Creatinine clearance: ≥ 50 mL/min (calculated using the Cockcroft and Gault formula).
- Life expectancy greater than six months prior to randomization.
Who cannot join
- Refusal to sign the Informed Consent Form (ICF).
- NSCLC clinical stages IA, IIIB N3, IIIC, IVA, and IVB.
- Tumors with T4 invasion of the aorta, esophagus, and/or heart; or presence of bulky N2 disease.
- Tumor deemed unresectable.
- Prior systemic anticancer therapy for NSCLC, including chemotherapy, biologic therapy, immunotherapy, or any investigational drugs.
- History of another primary malignancy, with exceptions for:
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- Malignancies treated with curative intent and no active disease for ≥ 2 years before the first dose of investigational product (IP) and with a low risk of recurrence.
- Adequately treated non-melanoma skin cancer or lentigo maligna with no evidence of disease.
- Adequately treated carcinoma in situ with no evidence of disease.
- Incomplete basic medical information in the electronic medical record.
- Positive for EGFR gene expression.
- Positive for ALK protein expression.
- No available data on PD-L1 protein expression.
- Positive for ROS1 protein expression.
- Pregnant or breastfeeding at the time of enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
ALINE FARES, MD contact
Brazil1 site, 1 recruiting
- Recruiting
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
São José do Rio Preto, São Paulo, 15090000
About this study
Official title: Efficacy Analysis of Neoadjuvant Treatment in Lung Cancer Using Low-Dose Nivolumab Combined With Chemotherapy
The primary objective of this study is to assess the major pathological response (MPR) rate and pathologic complete response (pCR) rate in stage IB-IIIA non-small cell lung cancer (NSCLC) treated with a low dose of neoadjuvant immunotherapy combined with platinum doublet.
- Being tested
- Low-dose nivolumab combined with platinum-based doublet chemotherapy
- Keywords
- Low Dose Immunotherapy, Neoadjuvant immunotherapy, Non-Small-Cell-Lung-Cancer
- 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.
Low-dose nivolumab combined with platinum-based doublet chemotherapyDrug
Platinum-based neoadjuvant chemotherapy (carboplatin at AUC 5 or 6 combined with either paclitaxel at 175 mg/m² or pemetrexed at 500 mg/m²), administered with nivolumab at 0.3 mg/kg every 21 days for 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose nivolumab combined with platinum-based doublet chemotherapy | Experimental | Not described Receives: Drug: Low-dose nivolumab combined with platinum-based doublet chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathologic Response
MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery.
Measured: 2-3 months
Pathologic Complete Response
Pathological complete response (pCR) is defined as having no residual cancer at the primary site or in regional lymph nodes on pathologic review of the surgical specimen.
Measured: 2-3 months
Secondary outcomes (3)
Adverse Events
TRAE is defined and classified according to NCI-CTCAE v5.0 in all participants.
Measured: Up to 3 months after the end of treatment
Event-Free-Survival
Event-free survival (EFS) is defined as the length of time (months) from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death.
Measured: Up to 60 months
R0 resection
R0 resection rate is defined as the proportion of participants who have achieved R0 resection (complete resection with no residual tumor cell in the resection margin) in all participants.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start10 Oct 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Nonsmall CellStudies 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
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aline Fusco Fares, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Base
- Responsible party
- Sponsor-investigator, Aline Fusco Fares, MD, Fundação Faculdade Regional de Medicina de São José do Rio Preto
- Investigators
- JOAO A SOLER, MD, Principal investigator, FUNDACAO FACULDADE REGIONAL DE MEDICINA DE SAO JOSE DO RIO PRETO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667154
- Sponsor's protocol ID
- LungCancerLowDose
- Status last verified
- Oct 2024
- First submitted
- 6 Jun 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Analysis of Neoadjuvant Treatment in Lung Cancer Using Low-Dose Nivolumab Combined With Chemotherapy
- ClinicalTrials.gov ID
- NCT06667154
- Acronym / sponsor ID
- LungCancerLowDose
- Keywords
- Low Dose Immunotherapy, Neoadjuvant immunotherapy, Non-Small-Cell-Lung-Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Aline Fusco Fares, MDUniversity, hospital or other
- Collaborators
- Hospital de Base
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the major pathological response (MPR) rate and pathologic complete response (pCR) rate in stage IB-IIIA non-small cell lung cancer (NSCLC) treated with a low dose of neoadjuvant immunotherapy combined with platinum doublet.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-dose nivolumab combined with platinum-based doublet chemotherapy | Experimental | Drug: Low-dose nivolumab combined with platinum-based doublet chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Able to provide a signed Informed Consent Form (ICF), indicating agreement to comply with the requirements and restrictions in the ICF and protocol.
- Male or female, aged 18 years or older.
- Diagnosed with non-small cell lung cancer (NSCLC) with clinical staging IB, II, or IIIA.
- Receiving treatment at Hospital de Base.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment, with no decline from two weeks prior to the baseline period or the day of the first dose.
Key exclusion criteria (15 listed)
- Refusal to sign the Informed Consent Form (ICF).
- NSCLC clinical stages IA, IIIB N3, IIIC, IVA, and IVB.
- Tumors with T4 invasion of the aorta, esophagus, and/or heart; or presence of bulky N2 disease.
- Tumor deemed unresectable.
- Prior systemic anticancer therapy for NSCLC, including chemotherapy, biologic therapy, immunotherapy, or any investigational drugs.
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 |
|---|---|---|
| Low-dose nivolumab combined with platinum-based doublet chemotherapyPlatinum-based neoadjuvant chemotherapy (carboplatin at AUC 5 or 6 combined with either paclitaxel at 175 mg/m² or pemetrexed at 500 mg/m²), administered with nivolumab at 0.3 mg/kg every 21 days for 3 cycles. | Drug | Low-dose nivolumab combined with platinum-based doublet chemotherapy |
Primary outcome
Major Pathologic Response
Time frame: 2-3 months
MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery.
Pathologic Complete Response
Time frame: 2-3 months
Pathological complete response (pCR) is defined as having no residual cancer at the primary site or in regional lymph nodes on pathologic review of the surgical specimen.
3 secondary outcomes
Adverse Events
Time frame: Up to 3 months after the end of treatment
Event-Free-Survival
Time frame: Up to 60 months
R0 resection
Time frame: Up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: Yes
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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.
ALINE FARES, MD contact
JOAO A SOLER, MD principal investigator
FUNDACAO FACULDADE REGIONAL DE MEDICINA DE SAO JOSE DO RIO PRETO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low-dose nivolumab combined with platinum-based doublet chemotherapy in people with Lung Cancer, Nonsmall Cell and Non-Small Cell Lung Cancer NSCLC, run by Aline Fusco Fares, MD at 1 site in Brazil.
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 19 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
Contact JOAO A SOLER, MD (+55 17 981350180, joao.soler@hbonco.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathologic Response (time frame: 2-3 months). The study lists 2 primary outcomes in all. 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 31 Oct 2024.