Non-small Cell Lung CancerPhase 3COMPELNCT04765059
A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients With Non-small Cell Lung Cancer (NSCLC)
A Phase 3 study testing Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin in people with Non-small Cell Lung Cancer, run by AstraZeneca at 40 sites in 6 countries.
Trial summary
The study will evaluate the efficacy and safety of treatment with chemotherapy in combination with osimertinib compared to chemotherapy in combination with placebo in patients whose disease has progressed extracranially following first-line osimertinib treatment. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 40 sitesin 6 countries
- Study dates
- 12 Sep 2021to 2 Jun 2027
- Phase
- Phase 3
- 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 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
- Pathologically confirmed non-squamous NSCLC.
- Locally advanced (clinical stage IIIB or IIIC) or metastatic NSCLC (clinical stage IVA or IVB) or recurrent NSCLC, not amenable to curative surgery or radiotherapy.
- Evidence of radiological extracranial disease progression following (Investigator-assessed) response or SD for ≥ 6 months during first-line osimertinib treatment, but who have not received further, subsequent treatment.
- Tumor known to harbor 1 of the 2 or both common epidermal growth factor receptor (EGFR) mutations known to be associated with EGFR tyrosine kinase inhibitor (TKI) sensitivity (Ex19del or L858R), either alone or in combination with other EGFR mutations, which may include T790M.
- World Health Organization performance status of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks.
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- Life expectancy >12 weeks at Day 1.
- At least 1 lesion, not previously irradiated, that can be accurately measured.
- Females must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of childbearing potential, or must have evidence of non-childbearing potential by fulfilling criteria at screening.
- Male patients must be willing to use barrier contraception
Who cannot join
- Clinical or radiological evidence of CNS progression on first-line osimertinib.
- Past medical history of interstitial lung disease (ILD)/pneumonitis, drug-induced ILD/pneumonitis, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD/pneumonitis.
- Any evidence of severe or uncontrolled systemic diseases.
- Any of the following cardiac criteria:
- Mean resting QTc >470 msec ii) Any clinically important abnormalities in rhythm, conduction, or morphology of resting electrocardiogram iii) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events
- Any concurrent and/or other active malignancy that has required treatment within 2 years of first dose of investigational product (IP).
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- Any unresolved toxicities from prior therapy.
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib.
- More than 4 weeks elapsed since last dose of osimertinib by date of randomization.
- Unable to tolerate osimertinib 80 mg first-line therapy.
- Prior treatment with any systemic anti-cancer therapy.
- Major surgery within 4 weeks of the first dose of IP.
- Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of IP.
- Current use of medications or herbal supplements known to be strong inducers of cytochrome P450 (CYP) 3A4.
- Participation in another clinical study with an IP other than first-line osimertinib during the 4 weeks prior to Day 1.
Trial locations and contacts
40 sites in 6 countries.
40 sites in 6 countries
Spain11 sites
Research Site
Alicante, 03010
Research Site
Barcelona, 08907
Research Site
Córdoba, 14004
Research Site
León, 24071
Research Site
Madrid, 28040
Research Site
Málaga, 29010
Research Site
Murcia, 30008
Research Site
Oviedo, 33011
Research Site
Palma de Mallorca, 07010
Research Site
Seville, 41013
Research Site
Valencia, 46010
China8 sites
Research Site
Beijing, 100005
Research Site
Beijing, 100142
Research Site
Ganzhou, 341099
Research Site
Guangzhou, 510080
Research Site
Jinan, 250013
Research Site
Shenyang, 110001
Research Site
Tianjin, 300060
Research Site
Zhengzhou, 450008
Italy8 sites
Research Site
Florence, 50134
Research Site
Meldola, 47014
Research Site
Messina, 98158
Research Site
Naples, 80131
Research Site
Padova, 35128
Research Site
Roma, 00168
Research Site
Terni, 05100
Research Site
Verona, 37124
Israel6 sites
Research Site
Beersheba, 84101
Research Site
Jerusalem, 9103102
Research Site
Jerusalem, 9112001
Research Site
Kfar Saba, 4428164
Research Site
Tel Aviv, 6423906
Research Site
Tel Litwinsky, 52621
Germany5 sites
Research Site
Berlin, 12351
Research Site
Cologne, 50937
Research Site
Cologne, 51109
Research Site
Hanover, 30625
Research Site
München, D-80336
United States2 sites
Research Site
Boston, Massachusetts, 02114
Research Site
Silver Spring, Maryland, 20910
About this study
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Platinum Plus Pemetrexed Chemotherapy Plus Osimertinib Versus Platinum Plus Pemetrexed Chemotherapy Plus Placebo in Patients With EGFRm, Locally Advanced or Metastatic NSCLC Who Have Progressed Extracranially Following First-Line Osimertinib Therapy (COMPEL)
The study will evaluate the efficacy and safety of treatment with chemotherapy in combination with osimertinib compared to chemotherapy in combination with placebo in patients whose disease has progressed extracranially following first-line osimertinib treatment.
Read the detailed description
This is a Phase III, randomized, double-blind, placebo-controlled study of platinum plus pemetrexed chemotherapy plus osimertinib versus platinum plus pemetrexed chemotherapy plus placebo in patients with epidermal growth factor receptor mutation-positive (EGFRm), locally advanced or metastatic NSCLC with or wihout stable brain metastases who responded to first-line osimertinib therapy (complete response [CR] or partial response [PR]) or stable disease (SD) for ≥ 6 months during first-line osimertinib treatment, and subsequently experienced radiological, extracranial disease progression. Approximately 204 patients were to be randomized in a 1:1 ratio to treatment with platinum plus pemetrexed chemotherapy plus osimertinib (Treatment Arm A) or platinum plus pemetrexed chemotherapy plus placebo (Treatment Arm B). However, the number of patients has been reduced to approximately 80 patients due to treatment landscape changes which outpaced study recruitment. Patients will be stratified based on the presence of brain metastases (stable brain metastases based on central nervous system (CNS) Response Evaluation Criteria in Solid Tumors, Version 1.1 [RECIST 1.1] assessments versus no brain metastases).
The 2 randomized treatment regimens are as follows:
- Treatment Arm A: Osimertinib 80 mg once daily (QD) with pemetrexed (500 mg/m^2) (with pre-treatment) plus either cisplatin (75 mg/m^2) or carboplatin (area under the concentration-time curve [AUC] 5), both administered on Day 1 of 21-day cycles for 4 cycles, followed by osimertinib 80 mg QD plus pemetrexed maintenance (500 mg/m^2) on Day 1 of 21-day cycles
- Treatment Arm B: Placebo QD with pemetrexed (500 mg/m^2) (with pre-treatment) plus either cisplatin (75 mg/m^2) or carboplatin (AUC5), both administered on Day 1 of 21-day cycles for 4 cycles, followed by placebo QD plus pemetrexed maintenance (500 mg/m^2) on Day 1 of 21-day cycles.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin, Placebo for osimertinib (AZD9291) pemetrexed cisplatin or carboplatin
- Keywords
- Osimertinib, Platinum, Pemetrexed, Epidermal growth factor receptor mutation positive (EGFRm), Extracranial progression
- 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.
Osimertinib (AZD9291) pemetrexed cisplatin or carboplatinDrug
Randomized patients will receive oral dose of osimertinib with intravenous (IV) pemetrexed plus either IV cisplatin or IV carboplatin
Placebo for osimertinib (AZD9291) pemetrexed cisplatin or carboplatinDrug
Randomized patients will receive oral dose of placebo matching osimertinib with IV pemetrexed plus either IV cisplatin or IV carboplatin
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm A | Experimental | All randomized patients will receive osimertinib 80 mg QD with pemetrexed (500 mg/m^2) (with pre-treatment) plus either cisplatin (75 mg/m^2) or carboplatin ([AUC] 5), both administered on Day 1 of 21-day cycles for 4 cycles, followed by osimertinib 80 mg QD plus pemetrexed maintenance (500 mg/m^2) on Day 1 of 21-day cycles Receives: Drug: Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin |
| Treatment Arm B | Placebo comparator | All randomized patients will receive placebo QD with pemetrexed (500 mg/m^2) (with pre-treatment) plus either cisplatin (75 mg/m^2) or carboplatin (AUC5), both administered on Day 1 of 21-day cycles for 4 cycles, followed by placebo QD plus pemetrexed maintenance (500 mg/m^2) on Day 1 of 21-day cycles Receives: Drug: Placebo for osimertinib (AZD9291) pemetrexed cisplatin or carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Progression free survival is defined as time from randomization until progression (intracranial or extracranial, whichever occurs first) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (for extracranial progression) and Central nervous system (CNS) RECIST 1.1 (for intracranial progression) as assessed by the Investigator at local site or death due to any cause.
Measured: From date of first dose (Day 1) until date of progression at local site or death due to any cause or data cut-off date whichever occurred first (up to 3 years 1 month)
Secondary outcomes (4)
Intracranial Progression Free Survival in Participants With Brain Metastases at Baseline
Intracranial PFS (IC-PFS) is defined as time from randomization until intracranial progression per CNS RECIST 1.1 as assessed by the Investigator at local site or death due to any cause.
For participants with brain metastases at baseline, the IC-PFS rate at specified timepoints was estimated using the Kaplan-Meier method which indicated the percentage of these participants who remain alive and free from intracranial progression per CNS RECIST 1.1 as assessed by the Investigator. The data was calculated throughout the study as per the below timeframe but IC-PFS rate at 6 months has been presented as it was clinically relevant.
Measured: Assessed from date of first dose (Day 1) until date of intracranial progression at local site or death due to any cause or data cut off date whichever occurred first (up to 3 years 1 month), data for 6 months reported
Intracranial Progression Free Survival in Participants Without Brain Metastases at Baseline
Intracranial PFS (IC-PFS) is defined as time from randomization until intracranial progression per CNS RECIST 1.1 as assessed by the Investigator at local site or death due to any cause.
For participants without brain metastases at baseline, the IC-PFS rate at specified timepoints was estimated using the Kaplan-Meier method which indicated the percentage of these participants who remain alive and free from intracranial progression per CNS RECIST 1.1 as assessed by the Investigator. The data was calculated throughout the study as per the below timeframe but IC-PFS rate at 6 months has been presented as it was clinically relevant.
Measured: Assessed from date of first dose (Day 1) until date of intracranial progression at local site or death due to any cause or data cut off date whichever occurred first (up to 3 years 1 month), data for 6 months reported
Extracranial Progression Free-survival
Extracranial PFS is defined as time from randomization until extracranial progression per RECIST 1.1 as assessed by the Investigator at local site or death due to any cause.
Measured: From date of first dose (Day 1) until date of extracranial progression at local site or death due to any cause or data cut-off date whichever occurred first (up to 3 years 1 month)
Overall Survival (OS)
Overall survival is defined as the length of time from randomization until the date of death due to any cause.
Measured: From date of first dose (Day 1) until post progression survival follow-up (up to 3 years 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start12 Sep 2021
- Primary completion28 Oct 2024
- Study completion2 Jun 2027 (estimated)
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 Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765059
- Sponsor's protocol ID
- D5162C00042
- Other IDs
- 2019-003969-18, 2019
- Acronym
- COMPEL
- Status last verified
- Jul 2026
- First submitted
- 11 Feb 2021
- Last updated
- 7 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Platinum Plus Pemetrexed Chemotherapy Plus Osimertinib Versus Platinum Plus Pemetrexed Chemotherapy Plus Placebo in Patients With EGFRm, Locally Advanced or Metastatic NSCLC Who Have Progressed Extracranially Following First-Line Osimertinib Therapy (COMPEL)
- ClinicalTrials.gov ID
- NCT04765059
- Acronym / sponsor ID
- COMPEL / D5162C00042
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Osimertinib, Platinum, Pemetrexed, Epidermal growth factor receptor mutation positive (EGFRm), Extracranial progression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 98 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 12 Sep 2021 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 2 Jun 2027 (estimated)
- First posted
- 21 Feb 2021 (actual)
- Results
- Posted 13 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate the efficacy and safety of treatment with chemotherapy in combination with osimertinib compared to chemotherapy in combination with placebo in patients whose disease has progressed extracranially following first-line osimertinib treatment.
Detailed description
This is a Phase III, randomized, double-blind, placebo-controlled study of platinum plus pemetrexed chemotherapy plus osimertinib versus platinum plus pemetrexed chemotherapy plus placebo in patients with epidermal growth factor receptor mutation-positive (EGFRm), locally advanced or metastatic NSCLC with or wihout stable brain metastases who responded to first-line osimertinib therapy (complete response [CR] or partial response [PR]) or stable disease (SD) for ≥ 6 months during first-line osimertinib treatment, and subsequently experienced radiological, extracranial disease progression. Approximately 204 patients were to be randomized in a 1:1 ratio to treatment with platinum plus pemetrexed chemotherapy plus osimertinib (Treatment Arm A) or platinum plus pemetrexed chemotherapy plus placebo (Treatment Arm B). However, the number of patients has been reduced to approximately 80 patients due to treatment landscape changes which outpaced study recruitment. Patients will be stratified based on the presence of brain metastases (stable brain metastases based on central nervous system (CNS) Response Evaluation Criteria in Solid Tumors, Version 1.1 [RECIST 1.1] assessments versus no brain metastases).
The 2 randomized treatment regimens are as follows:
- Treatment Arm A: Osimertinib 80 mg once daily (QD) with pemetrexed (500 mg/m^2) (with pre-treatment) plus either cisplatin (75 mg/m^2) or carboplatin (area under the concentration-time curve [AUC] 5), both administered on Day 1 of 21-day cycles for 4 cycles, followed by osimertinib 80 mg QD plus pemetrexed maintenance (500 mg/m^2) on Day 1 of 21-day cycles
- Treatment Arm B: Placebo QD with pemetrexed (500 mg/m^2) (with pre-treatment) plus either cisplatin (75 mg/m^2) or carboplatin (AUC5), both administered on Day 1 of 21-day cycles for 4 cycles, followed by placebo QD plus pemetrexed maintenance (500 mg/m^2) on Day 1 of 21-day cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm A | Experimental | Drug: Osimertinib (AZD9291) pemetrexed cisplatin or carboplatinAll randomized patients will receive osimertinib 80 mg QD with pemetrexed (500 mg/m^2) (with pre-treatment) plus either cisplatin (75 mg/m^2) or carboplatin ([AUC] 5), both administered on Day 1 of 21-day cycles for 4 cycles, followed by osimertinib 80 mg QD plus pemetrexed maintenance (500 mg/m^2) on Day 1 of 21-day cycles |
| Treatment Arm B | Placebo comparator | Drug: Placebo for osimertinib (AZD9291) pemetrexed cisplatin or carboplatinAll randomized patients will receive placebo QD with pemetrexed (500 mg/m^2) (with pre-treatment) plus either cisplatin (75 mg/m^2) or carboplatin (AUC5), both administered on Day 1 of 21-day cycles for 4 cycles, followed by placebo QD plus pemetrexed maintenance (500 mg/m^2) on Day 1 of 21-day cycles |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
- Pathologically confirmed non-squamous NSCLC.
- Locally advanced (clinical stage IIIB or IIIC) or metastatic NSCLC (clinical stage IVA or IVB) or recurrent NSCLC, not amenable to curative surgery or radiotherapy.
- Evidence of radiological extracranial disease progression following (Investigator-assessed) response or SD for ≥ 6 months during first-line osimertinib treatment, but who have not received further, subsequent treatment.
- Tumor known to harbor 1 of the 2 or both common epidermal growth factor receptor (EGFR) mutations known to be associated with EGFR tyrosine kinase inhibitor (TKI) sensitivity (Ex19del or L858R), either alone or in combination with other EGFR mutations, which may include T790M.
Key exclusion criteria (15 listed)
- Clinical or radiological evidence of CNS progression on first-line osimertinib.
- Past medical history of interstitial lung disease (ILD)/pneumonitis, drug-induced ILD/pneumonitis, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD/pneumonitis.
- Any evidence of severe or uncontrolled systemic diseases.
- Any of the following cardiac criteria:
- Any concurrent and/or other active malignancy that has required treatment within 2 years of first dose of investigational product (IP).
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 |
|---|---|---|
| Osimertinib (AZD9291) pemetrexed cisplatin or carboplatinRandomized patients will receive oral dose of osimertinib with intravenous (IV) pemetrexed plus either IV cisplatin or IV carboplatin | Drug | Treatment Arm A |
| Placebo for osimertinib (AZD9291) pemetrexed cisplatin or carboplatinRandomized patients will receive oral dose of placebo matching osimertinib with IV pemetrexed plus either IV cisplatin or IV carboplatin | Drug | Treatment Arm B |
Primary outcome
Progression Free Survival (PFS)
Time frame: From date of first dose (Day 1) until date of progression at local site or death due to any cause or data cut-off date whichever occurred first (up to 3 years 1 month)
Progression free survival is defined as time from randomization until progression (intracranial or extracranial, whichever occurs first) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (for extracranial progression) and Central nervous system (CNS) RECIST 1.1 (for intracranial progression) as assessed by the Investigator at local site or death due to any cause.
4 secondary outcomes
Intracranial Progression Free Survival in Participants With Brain Metastases at Baseline
Time frame: Assessed from date of first dose (Day 1) until date of intracranial progression at local site or death due to any cause or data cut off date whichever occurred first (up to 3 years 1 month), data for 6 months reported
Intracranial Progression Free Survival in Participants Without Brain Metastases at Baseline
Time frame: Assessed from date of first dose (Day 1) until date of intracranial progression at local site or death due to any cause or data cut off date whichever occurred first (up to 3 years 1 month), data for 6 months reported
Extracranial Progression Free-survival
Time frame: From date of first dose (Day 1) until date of extracranial progression at local site or death due to any cause or data cut-off date whichever occurred first (up to 3 years 1 month)
Overall Survival (OS)
Time frame: From date of first dose (Day 1) until post progression survival follow-up (up to 3 years 1 month)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Redacted CSPLink provided by the sponsor.
- Redacted SAPLink provided by the sponsor.
- Redacted CSR synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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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.
40 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin in people with Non-small Cell Lung Cancer, run by AstraZeneca at 40 sites in 6 countries.
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 10 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: under way, not looking for participants, as of the sponsor's last update on 7 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 40 sites in Spain, China, Italy, Israel, Germany and 1 more country. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 13 Jan 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?
Progression Free Survival (PFS) (time frame: From date of first dose (Day 1) until date of progression at local site or death due to any cause or data cut-off date whichever occurred first (up to 3 years 1 month)). 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 7 Jul 2026.