Lung NeoplasmsPhase 2PACIFIC BRAZILNCT04230408
Intensified Chemo-immuno-radiotherapy With Durvalumab for Stage III Non-Small Cell Lung Cancers
A Phase 2 study testing Durvalumab in people with Lung Neoplasms, run by Latin American Cooperative Oncology Group at 6 sites in Brazil.
Trial summary
This is a phase II study that will assess if Durvalumab (MEDI4736) used as induction chemo-immunotherapy followed by concurrent chemo-immuno-radiotherapy and consolidation immunotherapy may improve oncologic outcomes compared with standard of care chemoradiation followed by durvalumab (as in the PACIFIC trial) with a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Durvalumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 6 sitesBrazil
- Study dates
- 5 Mar 2021to 20 Dec 2024
- 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
- Histologically or cytologically confirmed non-small cell lung cancer.
- Stage III according to the American Joint Committee on Cancer (AJCC) Staging Manual, 8th edition.
- No prior systemic therapy, radiation therapy, or surgery for the current cancer.
- Age ≥ 18 years at time of study entry
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Body weight >30kg
- Pre- or post-bronchodilator forced expiratory volume 1 ≥ 1.2 litres/second or ≥ 50% of predicted value
- Adequate normal organ and marrow function
Who cannot join
- Patients whose radiation treatment is likely to encompass a volume of whole lung receiving ≥ 20 Gy in total of more than 35% of lung volume.
- Patients whose radiation treatment is likely to deliver a cardiac dose V50 > 25%
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
- Participation in another clinical study with an investigational product with anti-neoplastic activity during the last 3 weeks prior to treatment initiation
- Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
- History of allogenic organ transplantation.
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- Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
- Prior randomisation or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.
- Patients who have received prior anti-PD-1, anti PD-L1 or anti CTLA-4 antibodies
- Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product.
- Prior radiation therapy to the region of the study cancer that would result in overlap of radiation therapy fields.
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of the investigational product.
- Active or prior documented autoimmune or inflammatory disorders
- Uncontrolled intercurrent illness
- History of another primary malignancy
- Known active infection including tuberculosis , hepatitis B, hepatitis C, or human immunodeficiency virus.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Brazil6 sites
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, 59075-740
CPO
Porto Alegre, Rio Grande do Sul
INCA
Rio de Janeiro, Rio de Janeiro
COI Américas
Rio de Janeiro
Beneficiencia Portuguesa de São Paulo/Hospital São José
São Paulo
ICESP
São Paulo
About this study
Official title: Intensified Chemo-immuno-radiotherapy With Durvalumab (MEDI4736) for Stage III Non-Small Cell Lung Cancers (NSCLCs): a Brazilian Single Arm Phase II Study (PACIFIC BRAZIL)
This is a phase II study that will assess if Durvalumab (MEDI4736) used as induction chemo-immunotherapy followed by concurrent chemo-immuno-radiotherapy and consolidation immunotherapy may improve oncologic outcomes compared with standard of care chemoradiation followed by durvalumab (as in the PACIFIC trial) with a reasonable safety profile.
Read the detailed description
Prospective, non-randomized, open label, single arm, multi-institutional, phase 2 study, including patients with stage III non-small cell lung cancer able to receive concurrent chemoradiation. Eligible patients will then receive treatment as follows:
Induction chemo-immunotherapy Two 21-day cycles of carboplatin, paclitaxel and durvalumab will be given BEFORE concurrent chemo-immuno-radiotherapy.
Thereafter, patients without progressive disease (or patients with disease progression that is still locally advanced and can be safely encompassed within tolerable radiation fields) will receive concurrent chemo-immuno-radiotherapy, as follows:
Concurrent chemo-immuno-radiotherapy Concurrent carboplatin, paclitaxel, and durvalumab with radiation therapy, initiated preferably 3-5 weeks after the last dose of induction chemo-immunotherapy.
Thereafter, patients without progressive disease will receive consolidation immunotherapy, as follows:
Consolidation immunotherapy Twelve 28-day cycles of durvalumab will be given, initiated preferably within one week following concurrent chemo-immuno-radiotherapy.
- Conditions
- Lung Neoplasms
- Being tested
- Durvalumab
- Keywords
- Stage III Non-Small Cell Lung Cancer, Unresectable Non-Small Cell Lung Cancer, Durvalumab, MEDI4736
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called Carboplatin, Paclitaxel
Intensified chemo-immuno-radiotherapy with durvalumab in combination with carboplatin, paclitaxel and radiation
| Study group | Role | What they receive |
|---|---|---|
| DURVALUMAB (MEDI4736) + carboplatin-paclitaxel | Experimental | Induction chemo-immunotherapy phase:
Two cycles of Paclitaxel 200 mg/m2, Carboplatin AUC 6 and Durvalumab 1500 mg intravenously every 21 days.
Concurrent chemo-immuno-radiotherapy phase:
Radiation therapy concomitantly with: paclitaxel 50 mg/m2 intravenously every 7 days (+/- 3 days) until completion of radiation therapy, carboplatin AUC 2 intravenously every 7 days (+/- 3 days) until completion of radiation therapy and durvalumab 1500 mg intravenously every 21 days (+/- 6 days) for a maximum of 2 doses.
Concurrent chemo-immuno-radiotherapy:
Durvalumab 1500 mg intravenously every 28 days (+/- 7 days) for a maximum of 12 doses Receives: Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
12 months Progression-Free Survival
Proportion of patients who are alive and progression-free 12 months after cycle 1, day 1 of induction treatment, estimated by the Kaplan-Maier method and using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: Tumor scans will be performed at baseline, after the induction and concomitant phases and 3, 6, 9, and 12 months after the last dose of radiation therapy.
Secondary outcomes (3)
Overall Survival (OS)
Time from cycle 1, day 1 of induction treatment until death due to any cause.
Measured: OS will be evaluated until month 24 after C1D1.
Overall response rate to induction treatment
The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) using RECIST v1.1.
Measured: Tumor scans will be performed at baseline, after the induction and concomitant phases and 3, 6, 9, and 12 months after the last dose of radiation therapy.
Patterns of Failure
Rate of disease failure in local, regional and distant sites
Measured: Tumor scans will be performed at baseline, after the induction and concomitant phases and 3, 6, 9, and 12 months after the last dose of radiation therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start5 Mar 2021
- Primary completion7 Oct 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies 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
- Prospective single-arm study
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latin American Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Libbs Farmacêutica LTDA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230408
- Sponsor's protocol ID
- LACOG 2218
- Acronym
- PACIFIC BRAZIL
- Status last verified
- Feb 2025
- First submitted
- 10 Jan 2020
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensified Chemo-immuno-radiotherapy With Durvalumab (MEDI4736) for Stage III Non-Small Cell Lung Cancers (NSCLCs): a Brazilian Single Arm Phase II Study (PACIFIC BRAZIL)
- ClinicalTrials.gov ID
- NCT04230408
- Acronym / sponsor ID
- PACIFIC BRAZIL / LACOG 2218
- Conditions
- Lung Neoplasms
- Keywords
- Stage III Non-Small Cell Lung Cancer, Unresectable Non-Small Cell Lung Cancer, Durvalumab, MEDI4736
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Latin American Cooperative Oncology GroupUniversity, hospital or other
- Collaborators
- AstraZeneca, Libbs Farmacêutica LTDA
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 7 Oct 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 18 Jan 2020 (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.
This is a phase II study that will assess if Durvalumab (MEDI4736) used as induction chemo-immunotherapy followed by concurrent chemo-immuno-radiotherapy and consolidation immunotherapy may improve oncologic outcomes compared with standard of care chemoradiation followed by durvalumab (as in the PACIFIC trial) with a reasonable safety profile.
Detailed description
Prospective, non-randomized, open label, single arm, multi-institutional, phase 2 study, including patients with stage III non-small cell lung cancer able to receive concurrent chemoradiation. Eligible patients will then receive treatment as follows:
Induction chemo-immunotherapy Two 21-day cycles of carboplatin, paclitaxel and durvalumab will be given BEFORE concurrent chemo-immuno-radiotherapy.
Thereafter, patients without progressive disease (or patients with disease progression that is still locally advanced and can be safely encompassed within tolerable radiation fields) will receive concurrent chemo-immuno-radiotherapy, as follows:
Concurrent chemo-immuno-radiotherapy Concurrent carboplatin, paclitaxel, and durvalumab with radiation therapy, initiated preferably 3-5 weeks after the last dose of induction chemo-immunotherapy.
Thereafter, patients without progressive disease will receive consolidation immunotherapy, as follows:
Consolidation immunotherapy Twelve 28-day cycles of durvalumab will be given, initiated preferably within one week following concurrent chemo-immuno-radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single-arm study
| Arm | Type | Receives |
|---|---|---|
| DURVALUMAB (MEDI4736) + carboplatin-paclitaxel | Experimental | Drug: DurvalumabInduction chemo-immunotherapy phase: Two cycles of Paclitaxel 200 mg/m2, Carboplatin AUC 6 and Durvalumab 1500 mg intravenously every 21 days. Concurrent chemo-immuno-radiotherapy phase: Radiation therapy concomitantly with: paclitaxel 50 mg/m2 intravenously every 7 days (+/- 3 days) until completion of radiation therapy, carboplatin AUC 2 intravenously every 7 days (+/- 3 days) until completion of radiation therapy and durvalumab 1500 mg intravenously every 21 days (+/- 6 days) for a maximum of 2 doses. Concurrent chemo-immuno-radiotherapy: Durvalumab 1500 mg intravenously every 28 days (+/- 7 days) for a maximum of 12 doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed non-small cell lung cancer.
- Stage III according to the American Joint Committee on Cancer (AJCC) Staging Manual, 8th edition.
- No prior systemic therapy, radiation therapy, or surgery for the current cancer.
- Age ≥ 18 years at time of study entry
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (17 listed)
- Patients whose radiation treatment is likely to encompass a volume of whole lung receiving ≥ 20 Gy in total of more than 35% of lung volume.
- Patients whose radiation treatment is likely to deliver a cardiac dose V50 > 25%
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
- Participation in another clinical study with an investigational product with anti-neoplastic activity during the last 3 weeks prior to treatment initiation
- Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
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 |
|---|---|---|
| DurvalumabAlso: Carboplatin, PaclitaxelIntensified chemo-immuno-radiotherapy with durvalumab in combination with carboplatin, paclitaxel and radiation | Drug | DURVALUMAB (MEDI4736) + carboplatin-paclitaxel |
Primary outcome
12 months Progression-Free Survival
Time frame: Tumor scans will be performed at baseline, after the induction and concomitant phases and 3, 6, 9, and 12 months after the last dose of radiation therapy.
Proportion of patients who are alive and progression-free 12 months after cycle 1, day 1 of induction treatment, estimated by the Kaplan-Maier method and using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
3 secondary outcomes
Overall Survival (OS)
Time frame: OS will be evaluated until month 24 after C1D1.
Overall response rate to induction treatment
Time frame: Tumor scans will be performed at baseline, after the induction and concomitant phases and 3, 6, 9, and 12 months after the last dose of radiation therapy.
Patterns of Failure
Time frame: Tumor scans will be performed at baseline, after the induction and concomitant phases and 3, 6, 9, and 12 months after the last dose of radiation 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 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 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 Durvalumab in people with Lung Neoplasms, run by Latin American Cooperative Oncology Group at 6 sites 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 8 inclusion and 17 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 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
12 months Progression-Free Survival (time frame: Tumor scans will be performed at baseline, after the induction and concomitant phases and 3, 6, 9, and 12 months after the last dose of radiation 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 Feb 2025.