Lung NeoplasmPhase 2BLISSNCT05081674
Brazilian Lung Immunotherapy Study
A Phase 2 study testing Alectinib, Pembrolizumab and Nivolumab in people with Lung Neoplasm, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial summary
Immunotherapy with anti-PD-1/PD-L1 agents either as single agents or combined with chemotherapy is now considered the standard of care for patients with non-small-cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasm
- What is being tested?
- Alectinib, Pembrolizumab and Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2020to 30 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Stage IIIc or IV Non-small cell lung cancer
- Good performance status (ECOG 0-2)
- Available tissue for tumor markers
- Plan to undergo systemic therapy
Who cannot join
- Inadequate cardiac, renal, liver of bone-marrow function
- Plan to undergo definitive radiation or curative surgery
- Consent withdraw
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Costs and Outcomes of the Implementation of Treatment Protocol Based on Rational Utilization of Anti-PD1 Agents in Patients With Non-small-cell Lung Cancer in the Brazilian Public Health System
Immunotherapy with anti-PD-1/PD-L1 agents either as single agents or combined with chemotherapy is now considered the standard of care for patients with non-small-cell lung cancer. However, it has not been incorporated in the Brazilian Public Health System because of concerns about patient eligibility, safety and costs. It is known that simple biomarkers can be used to select patients for immunotherapy, such as EGRF, ALK and PD-L1 status in the tumors. We created a treatment protocol based on these 3 markers and treated 154 patients with non-small-cell-lung cancer in a Public Hospital in Brazil. The goal of this project is to identify the prevalence of these markers in the Brazilian population (to estimate patient eligibility), outcomes and costs of therapy.
Read the detailed description
Patients with metastatic non-small-cell lung cancer will undergo tumor testing for EGFR (by PCR), ALK and PD-L1 (by immunohistochemistry) and receive therapy based on these results.
- Patients with ALK-translocated tumors will receive first-line therapy with Alectinib, second-line therapy with carboplatin and pemetrexed and third-line therapy with docetaxel
- Patients with EGFR-mutated tumors will receive first-line therapy with Erlotinib, second-line therapy with carboplatin and pemetrexed and third-line therapy with docetaxel
- Patients with ALK/EGFRwt tumors and PD-L1>=50% will receive first-line pembrolizumab, second-line carboplatin-pemetrexed and third line docetaxel
- Patients with ALK/EGFRwt tumors and PD-L1<50% will receive first-line carboplatin-pemetrexed, second-line nivolumab and third line docetaxel.
Therapy costs will be estimated, including hospital admissions and reported for each treatment arm.
- Conditions
- Lung Neoplasm
- Being tested
- Alectinib, Pembrolizumab, Nivolumab, Erlotinib
- Keywords
- Non-small cell lung cancer, NSCLC, Lung adenocarcinoma, Squamous cell carcinoma of the lung, Immunotherapy, PD-1, Nivolumab, Pembrolizumab
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlectinibDrug
Also called Alecensa
600mg 1OD
PembrolizumabDrug
Also called Keytruda
200mg every 21 days
NivolumabDrug
Also called Opdivo
6mg/kg every 4 weeks
ErlotinibDrug
Also called Tarceva
150mg
| Study group | Role | What they receive |
|---|---|---|
| ALK-translocated | Active comparator | 1. st line Alectinib
2. nd line Carboplatin pemetrexed
3. rd line Docetaxel Receives: Drug: Alectinib |
| EGFR-mutant | Active comparator | 1. st line Erlotinib
2. nd line Carboplatin pemetrexed
3. rd line Docetaxel Receives: Drug: Erlotinib |
| PD-L1 >= 50% | Active comparator | 1. st line Pembrolizumab
2. nd line Carboplatin pemetrexed
3. rd line Docetaxel Receives: Drug: Pembrolizumab |
| PD-L1< 50% | Active comparator | 1. st line Carboplatin pemetrexed
2. nd line nivolumab
3. rd line Docetaxel Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cost of therapy
Sum of all direct costs involved in patient care, including admissions
Measured: Up to 3 years after starting systemic therapy
Secondary outcomes (2)
Median overall survival
Median survival from first systemic therapy
Measured: Up to 3 years after starting systemic therapy
Prevalence of ALK, EGFR, PD-L1>=50%
Prevalence of the 3 biomarkers in an unselected NSCLC population in Brazil
Measured: Up to 3 years after starting systemic therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start1 Jan 2020
- Primary completion30 Jun 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients are treated in one of 4 different arms based on biomarker testing. There is no randomization or cross-over
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Responsible party
- Sponsor
- Investigators
- Diogo Gomes, MD, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081674
- Sponsor's protocol ID
- 4009-19
- Acronym
- BLISS
- Status last verified
- Oct 2021
- First submitted
- 5 Oct 2021
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Costs and Outcomes of the Implementation of Treatment Protocol Based on Rational Utilization of Anti-PD1 Agents in Patients With Non-small-cell Lung Cancer in the Brazilian Public Health System
- ClinicalTrials.gov ID
- NCT05081674
- Acronym / sponsor ID
- BLISS / 4009-19
- Conditions
- Lung Neoplasm
- Keywords
- Non-small cell lung cancer, NSCLC, Lung adenocarcinoma, Squamous cell carcinoma of the lung, Immunotherapy, PD-1, Nivolumab, Pembrolizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 18 Oct 2021 (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.
Immunotherapy with anti-PD-1/PD-L1 agents either as single agents or combined with chemotherapy is now considered the standard of care for patients with non-small-cell lung cancer. However, it has not been incorporated in the Brazilian Public Health System because of concerns about patient eligibility, safety and costs. It is known that simple biomarkers can be used to select patients for immunotherapy, such as EGRF, ALK and PD-L1 status in the tumors. We created a treatment protocol based on these 3 markers and treated 154 patients with non-small-cell-lung cancer in a Public Hospital in Brazil. The goal of this project is to identify the prevalence of these markers in the Brazilian population (to estimate patient eligibility), outcomes and costs of therapy.
Detailed description
Patients with metastatic non-small-cell lung cancer will undergo tumor testing for EGFR (by PCR), ALK and PD-L1 (by immunohistochemistry) and receive therapy based on these results.
- Patients with ALK-translocated tumors will receive first-line therapy with Alectinib, second-line therapy with carboplatin and pemetrexed and third-line therapy with docetaxel
- Patients with EGFR-mutated tumors will receive first-line therapy with Erlotinib, second-line therapy with carboplatin and pemetrexed and third-line therapy with docetaxel
- Patients with ALK/EGFRwt tumors and PD-L1>=50% will receive first-line pembrolizumab, second-line carboplatin-pemetrexed and third line docetaxel
- Patients with ALK/EGFRwt tumors and PD-L1<50% will receive first-line carboplatin-pemetrexed, second-line nivolumab and third line docetaxel.
Therapy costs will be estimated, including hospital admissions and reported for each treatment arm.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Patients are treated in one of 4 different arms based on biomarker testing. There is no randomization or cross-over
| Arm | Type | Receives |
|---|---|---|
| ALK-translocated | Active comparator | Drug: Alectinib1. st line Alectinib 2. nd line Carboplatin pemetrexed 3. rd line Docetaxel |
| EGFR-mutant | Active comparator | Drug: Erlotinib1. st line Erlotinib 2. nd line Carboplatin pemetrexed 3. rd line Docetaxel |
| PD-L1 >= 50% | Active comparator | Drug: Pembrolizumab1. st line Pembrolizumab 2. nd line Carboplatin pemetrexed 3. rd line Docetaxel |
| PD-L1< 50% | Active comparator | Drug: Nivolumab1. st line Carboplatin pemetrexed 2. nd line nivolumab 3. rd line Docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stage IIIc or IV Non-small cell lung cancer
- Good performance status (ECOG 0-2)
- Available tissue for tumor markers
- Plan to undergo systemic therapy
Key exclusion criteria (3 listed)
- Inadequate cardiac, renal, liver of bone-marrow function
- Plan to undergo definitive radiation or curative surgery
- Consent withdraw
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 |
|---|---|---|
| AlectinibAlso: Alecensa600mg 1OD | Drug | ALK-translocated |
| PembrolizumabAlso: Keytruda200mg every 21 days | Drug | PD-L1 >= 50% |
| NivolumabAlso: Opdivo6mg/kg every 4 weeks | Drug | PD-L1< 50% |
| ErlotinibAlso: Tarceva150mg | Drug | EGFR-mutant |
Primary outcome
Total cost of therapy
Time frame: Up to 3 years after starting systemic therapy
Sum of all direct costs involved in patient care, including admissions
2 secondary outcomes
Median overall survival
Time frame: Up to 3 years after starting systemic therapy
Prevalence of ALK, EGFR, PD-L1>=50%
Time frame: Up to 3 years after starting systemic therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Web site of the Brazilian Ministry of HealthLink 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.
Diogo Gomes, MD principal investigator
Hospital Israelita Albert Einstein
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 Alectinib, Pembrolizumab and Nivolumab in people with Lung Neoplasm, run by Hospital Israelita Albert Einstein 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 4 inclusion and 3 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 11 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total cost of therapy (time frame: Up to 3 years after starting systemic therapy). 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 11 Oct 2023.