Platinum Refractory Extensive-Stage Small Cell Lung CarcinomaPhase 2NCT02937818
A Phase II, Study to Determine the Preliminary Efficacy of Novel Combinations of Treatment in Patients With Platinum Refractory Extensive-Stage Small-Cell Lung Cancer
A Phase 2 study testing Durvalumab and Tremelimumab, AZD1775 and carboplatin (CBPT) and AZD6738 and olaparib in people with Platinum Refractory Extensive-Stage Small Cell Lung Carcinoma, run by AstraZeneca at 12 sites in 5 countries.
Trial summary
Study design This is a Phase II, open-label, multi-drug, multi-center, multi-arm, signal-searching study in patients with extensive-stage small-cell lung cancer (SCLC) who have refractory or resistant disease from prior platinum-based chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Platinum Refractory Extensive-Stage Small Cell Lung Carcinoma
- What is being tested?
- Durvalumab and Tremelimumab, AZD1775 and carboplatin (CBPT) and AZD6738 and olaparib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 12 sitesin 5 countries
- Study dates
- 28 Nov 2016to 27 Nov 2023
- 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 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with histologically or cytologically documented ED SCLC who have demonstrated progressive disease either during first-line platinum-based chemotherapy (platinum refractory) or within 90 days of completing platinum based-chemotherapy (platinum resistant) and have not received further treatment.
- Brain metastases must be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment.
- At least 1 lesion, not previously irradiated, that can be accurately measured at baseline (per RECIST v 1.1 guidelines)
- Life expectancy of at least 8 weeks.
- WHO/ ECOG PS of 0-1 at enrollment.
- Body weight >30 kg.
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- No prior exposure to immune mediated therapy, excluding therapeutic anticancer vaccines.
- Inclusion criteria (Arm B specific) • Able and willing to swallow oral medication.
- Able and willing to swallow oral medication.
Who cannot join
- Participation in another clinical study, major surgery, radiation therapy within 28 days.
- Any condition that, in the opinion of the Investigator, would interfere with the evaluation of the IP or interpretation of patient safety or study results.
- Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
- History of another primary malignancy, leptomeningeal carcinomatosis or spinal cord compression.
- Active autoimmune disease, including a paraneoplastic syndrome.
- Active or prior documented autoimmune or inflammatory disorders.
Show all 23Show fewer
- Any unresolved toxicity (CTCAE Grade >2) from previous anticancer therapy.
- Active infection including tuberculosis, HIV, Hepatitis B or C.
- Prior exposure to any WEE1 inhibitors.
- Products known to be sensitive to CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong inhibitors/inducers of CYP3A4. Co-administration of rosuvastatin, atorvastatin, simvastatin and lovastatin, aprepitant or fosaprepitant or any herbal preparations. Grapefruit and Seville oranges should be avoided while taking AZD1775.
- Any known hypersensitivity or contraindication to IP or CBDP.
- QTcF > 470 msec or congenital long QT syndrome.
- Any current or within 6 months cardiac diseases NYHA ≥ Class 2: unstable angina pectoris, congestive heart failure, acute MI, conduction abnormality not controlled with pacemaker or medication, significant ventricular or supraventricular arrhythmias.
- A recent history of Torsades de pointes.
- Cytotoxic chemotherapy within 21 days of Cycle 1 Day 1 is not permitted
- Previous treatment with a PARP inhibitor (including olaparib) or ATR inhibitor
- Concomitant use of known strong CYP3A inhibitors and moderate CYP3A inhibitors
- Concomitant use of known strong and moderate CYP3A inducers
- Persisting (> 4 weeks) severe pancytopenia due to previous therapy
- Cardiac dysfunction
- Refractory nausea and vomitting, chronic gastrointenstinal diseases or previous significant bowel resection
- Patients with uncontrolled seizures
- Intenstinal obstruction or CTCAE grade 3 or grade 4 GI bleeding within 4 weeks before dosing
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
Hungary4 sites
Research Site
Kecskemét, 6000
Research Site
Miskolc, 3529
Research Site
Székesfehérvár, 8000
Research Site
Törökbálint, 2045
Ukraine3 sites
Research Site
Dnipro, 49102
Research Site
Ivano-Frankivsk, 76018
Research Site
Sumy, 40022
About this study
Official title: A Phase II, Open-Label, Multi-Arm Study to Determine the Preliminary Efficacy of Novel Combinations of Treatment in Patients With Platinum Refractory Extensive-Stage Small-Cell Lung Cancer
Study design This is a Phase II, open-label, multi-drug, multi-center, multi-arm, signal-searching study in patients with extensive-stage small-cell lung cancer (SCLC) who have refractory or resistant disease from prior platinum-based chemotherapy.
Read the detailed description
This study is modular in design, allowing evaluation of the preliminary efficacy, safety, tolerability, and immunogenicity of novel combinations of immunotherapies and/or deoxyribonucleic acid (DNA) damage repair inhibitors in patients with platinum refractory or resistant extensive-stage-disease SCLC. Patients who have progressive disease (PD) during first-line platinum-based chemotherapy (platinum refractory) or PD within 90 days after completing first-line platinum-based chemotherapy (platinum resistant) will be enrolled to the study. The primary objective of the study is to assess the preliminary efficacy of each treatment arm based on objective response rate (ORR).
This study consists of a number of arms (sub-studies), each evaluating the efficacy, safety, and tolerability of a specific agent or combination. This study was initially open with 2 arms (Arms A and B), and additional arms may open, provided there is compelling rationale for the combination and safe and tolerable doses and schedules have been determined from ongoing Phase I studies. There are 2 pre-defined arms:
- Durvalumab + tremelimumab followed by durvalumab monotherapy B. AZD1775 + carboplatin (CBDP)
Further arm was added in amendment 3:
- AZD6738 + olaparib Amendment #4 was updated with possibility to allow expansion of any arm, to a total of 40 eligible subjects, based on Review Committee assessment of data from the first 20 subjects (from Stage 1 and Stage 2). Currently Arm A will enroll 20 additional patients into expansion.
- Being tested
- Durvalumab and Tremelimumab, AZD1775 and carboplatin (CBPT), AZD6738 and olaparib
- Keywords
- Platinum Refractory Extensive-Stage Carcinoma, Small Cell Lung, Platinum Refractory Extensive-Stage Oat Cell Carcinoma of Lung, Platinum Refractory Extensive-Stage Oat Cell Lung Cancer, Platinum Refractory Extensive-Stage Small Cell Cancer Of The Lung, Platinum Refractory Extensive-Stage Small Cell Lung Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Durvalumab and TremelimumabDrug
Durvalumab + tremelimumab via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy via IV infusion q4w, starting on Week 16 until PD, or for other discontinuation criteria.
AZD1775 and carboplatin (CBPT)Drug
AZD1775 twice daily (oral) for 2.5 days from Day 1 + CBDP area under the curve 5 (Day1) (IV); every 3 weeks.
AZD6738 and olaparibDrug
AZD6738 once a day (oral) for 7 days from Day 1 + olaparib twice a day(oral) for 28 days from Day 1, every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| ARM A | Experimental | Not described Receives: Drug: Durvalumab and Tremelimumab |
| ARM B | Experimental | Not described Receives: Drug: AZD1775 and carboplatin (CBPT) |
| ARM C | Experimental | Not described Receives: Drug: AZD6738 and olaparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Overall Response
Overall Response Rate (ORR) using Investigator assessments according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. ORR was defined as the number (percentage) of participants with a confirmed Complete Response (CR) or confirmed Partial Response (PR) and was estimated for each treatment arm with corresponding 2-sided 95% exact confidence intervals (CIs). A confirmed response of CR/PR meant that a response of CR/PR was recorded at one visit and confirmed by repeat imaging, preferably at the next regularly scheduled imaging visit, and not less than 4 weeks after the visit when the response was first observed, with no evidence of progression between the initial and CR/PR confirmation visit.
Measured: Until disease progression [PD] (Up to 3.5 Years)
Secondary outcomes (17)
Duration of Response (DoR)
The DoR was defined as the time from the date of first documented response (which was subsequently confirmed) CR/PR until the date of documented progression, or death in the absence of disease progression. The DoR in participants with confirmed objective response are reported.
Measured: Until disease progression or data cut-off or Death (Up to 3.5 Years)
Percentage of Participants With Disease Control at 12 Weeks
The disease control rate (DCR) at 12 weeks was defined as the percentage of participants who had a best objective response of CR or PR in the first 13 weeks or who had demonstrated stable disease (SD) for a minimum interval of 11 weeks following the start of study treatment. The DCR was determined programmatically based on RECIST 1.1 using site Investigator data and all data up until the first progression event.
Measured: At 12 Weeks
Time to Response (TTR)
The TTR (per RECIST 1.1 as assessed by the Investigator) was defined as the time from the date of first dose until the first date of documented response.
Measured: Until disease progression or data cut-off or Death (Up to 3.5 Years)
Progression Free Survival (PFS)
The PFS (per RECIST 1.1 according to the Investigator's assessment) was defined as the time from the date of the first dose of study treatment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from allocated therapy or received another anti-cancer therapy prior to progression.
Measured: Until disease progression or data cut-off or Death (Up to 3.5 Years)
Overall Survival (OS)
The OS was defined as the time from the date of the first dose of study treatment until death due to any cause.
Measured: Until disease progression or data cut-off or Death (Up to 3.5 Years)
Time to Maximum Concentration (Tmax)
Time to maximum concentration for ceralasertib and olaparib are reported.
Measured: Cycle 1 (each cycle was 28 days in length) Day 1 (post-dose)
Maximum Concentration (Cmax)
Maximum concentration for ceralasertib and olaparib are reported.
Measured: Cycle 1 (each cycle was 28 days in length) Day 1 (post-dose)
Partial Area Under the Concentration-time Curve (AUC0-6)
Partial area under the concentration-time curve for ceralasertib and olaparib are reported.
Measured: Cycle 1 (each cycle was 28 days in length) Day 1 (post-dose) and Cycle 1 Day 7 (pre-dose and post-dose)
Area Under the Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t)
Area under the concentration-time curve from time zero to the last measurable concentration for Ceralasertib and Olaparib are reported.
Measured: Cycle 1 (each cycle was 28 days in length) Day 1 (post-dose) and Cycle 1 Day 7 (pre-dose and post-dose)
Time to Maximum Concentration at Steady State (Tmax,ss)
Time to maximum concentration at steady state for Ceralasertib and Olaparib are reported.
Measured: Cycle 1 (each cycle was 28 days in length) Day 7 (pre-dose and post-dose)
Maximum Concentration at Steady State (Cmax,ss)
Maximum concentration at steady state for Ceralasertib and Olaparib are reported.
Measured: Cycle 1 (each cycle was 28 days in length) Day 7 (pre-dose and post-dose)
Minimum Concentration at Steady State (Cmin,ss)
Minimum concentration at steady state for Ceralasertib and Olaparib are reported.
Measured: Cycle 1 (each cycle was 28 days in length) Day 7 (pre-dose and post-dose)
Area Under the Concentration-time Curve at Steady State (AUCss)
Area under the concentration-time curve at steady state at steady state for Ceralasertib and Olaparib are reported.
Measured: Cycle 1 (each cycle was 28 days in length) Day 7 (pre-dose and post-dose)
Apparent Clearance of Drug at Steady State at Steady State (CLss/F)
Area under the concentration-time curve at steady state at steady state for Ceralasertib and Olaparib are reported.
Measured: Cycle 1 (each cycle was 28 days in length) Day 7 (pre-dose and post-dose)
Serum Concentrations of Durvalumab and Tremelimumab
Serum concentrations of Durvalumab and Tremelimumab are reported.
Measured: Durvalumab: Cycle 1 (each cycle was 4 weeks) Day 1(post-dose); Cycle 2 Day 1(pre-dose); Cycle 5 Day 1 (pre-dose); Tremelimumab: Cycle 1 (each cycle was 4 weeks) Day 1 (post-dose); Cycle 2 Day 1 (pre-dose); Cycle 5 Day 1 (No dose); Cycle 7 Day 1 (No dose)
Plasma Concentrations of Adavosertib and Carboplatin
Plasma concentrations of Adavosertib and Carboplatin are reported.
Measured: Adavosertib: Cycle 1 (each cycle was 21 days) Day 3 (pre-dose and post-dose); Cycle 3 Day 3 (pre-dose and post-dose); Carboplatin: Cycle 1 (each cycle was 21 days) Day 1 (post-dose)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. SAE is an AE that results in any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, or is a significant medical event.
Measured: Day 1 until disease progression, and follow-up visit (Up to 3.5 Years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study start28 Nov 2016
- Primary completion22 Jun 2020
- Study completion27 Nov 2023
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 Platinum Refractory Extensive-Stage Small Cell Lung CarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Haiyi Jiang, M.D., Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937818
- Sponsor's protocol ID
- D419QC00002
- Other IDs
- 2016-001202-42, 2016
- Status last verified
- May 2024
- First submitted
- 5 Oct 2016
- Last updated
- 7 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Multi-Arm Study to Determine the Preliminary Efficacy of Novel Combinations of Treatment in Patients With Platinum Refractory Extensive-Stage Small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02937818
- Acronym / sponsor ID
- D419QC00002
- Keywords
- Platinum Refractory Extensive-Stage Carcinoma, Small Cell Lung, Platinum Refractory Extensive-Stage Oat Cell Carcinoma of Lung, Platinum Refractory Extensive-Stage Oat Cell Lung Cancer, Platinum Refractory Extensive-Stage Small Cell Cancer Of The Lung, Platinum Refractory Extensive-Stage Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2016 (actual)
- Primary completion
- 22 Jun 2020 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 19 Oct 2016 (estimated)
- Results
- Posted 9 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study design This is a Phase II, open-label, multi-drug, multi-center, multi-arm, signal-searching study in patients with extensive-stage small-cell lung cancer (SCLC) who have refractory or resistant disease from prior platinum-based chemotherapy.
Detailed description
This study is modular in design, allowing evaluation of the preliminary efficacy, safety, tolerability, and immunogenicity of novel combinations of immunotherapies and/or deoxyribonucleic acid (DNA) damage repair inhibitors in patients with platinum refractory or resistant extensive-stage-disease SCLC. Patients who have progressive disease (PD) during first-line platinum-based chemotherapy (platinum refractory) or PD within 90 days after completing first-line platinum-based chemotherapy (platinum resistant) will be enrolled to the study. The primary objective of the study is to assess the preliminary efficacy of each treatment arm based on objective response rate (ORR).
This study consists of a number of arms (sub-studies), each evaluating the efficacy, safety, and tolerability of a specific agent or combination. This study was initially open with 2 arms (Arms A and B), and additional arms may open, provided there is compelling rationale for the combination and safe and tolerable doses and schedules have been determined from ongoing Phase I studies. There are 2 pre-defined arms:
- Durvalumab + tremelimumab followed by durvalumab monotherapy B. AZD1775 + carboplatin (CBDP)
Further arm was added in amendment 3:
- AZD6738 + olaparib Amendment #4 was updated with possibility to allow expansion of any arm, to a total of 40 eligible subjects, based on Review Committee assessment of data from the first 20 subjects (from Stage 1 and Stage 2). Currently Arm A will enroll 20 additional patients into expansion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ARM A | Experimental | Drug: Durvalumab and Tremelimumab |
| ARM B | Experimental | Drug: AZD1775 and carboplatin (CBPT) |
| ARM C | Experimental | Drug: AZD6738 and olaparib |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults with histologically or cytologically documented ED SCLC who have demonstrated progressive disease either during first-line platinum-based chemotherapy (platinum refractory) or within 90 days of completing platinum based-chemotherapy (platinum resistant) and have not received further treatment.
- Brain metastases must be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment.
- At least 1 lesion, not previously irradiated, that can be accurately measured at baseline (per RECIST v 1.1 guidelines)
- Life expectancy of at least 8 weeks.
- WHO/ ECOG PS of 0-1 at enrollment.
Key exclusion criteria (23 listed)
- Participation in another clinical study, major surgery, radiation therapy within 28 days.
- Any condition that, in the opinion of the Investigator, would interfere with the evaluation of the IP or interpretation of patient safety or study results.
- Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
- History of another primary malignancy, leptomeningeal carcinomatosis or spinal cord compression.
- Active autoimmune disease, including a paraneoplastic syndrome.
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 |
|---|---|---|
| Durvalumab and TremelimumabDurvalumab + tremelimumab via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy via IV infusion q4w, starting on Week 16 until PD, or for other discontinuation criteria. | Drug | ARM A |
| AZD1775 and carboplatin (CBPT)AZD1775 twice daily (oral) for 2.5 days from Day 1 + CBDP area under the curve 5 (Day1) (IV); every 3 weeks. | Drug | ARM B |
| AZD6738 and olaparibAZD6738 once a day (oral) for 7 days from Day 1 + olaparib twice a day(oral) for 28 days from Day 1, every 4 weeks | Drug | ARM C |
Primary outcome
Number of Participants With Overall Response
Time frame: Until disease progression [PD] (Up to 3.5 Years)
Overall Response Rate (ORR) using Investigator assessments according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. ORR was defined as the number (percentage) of participants with a confirmed Complete Response (CR) or confirmed Partial Response (PR) and was estimated for each treatment arm with corresponding 2-sided 95% exact confidence intervals (CIs). A confirmed response of CR/PR meant that a response of CR/PR was recorded at one visit and confirmed by repeat imaging, preferably at the next regularly scheduled imaging visit, and not less than 4 weeks after the visit when the response was first observed, with no evidence of progression between the initial and CR/PR confirmation visit.
17 secondary outcomes
Duration of Response (DoR)
Time frame: Until disease progression or data cut-off or Death (Up to 3.5 Years)
Percentage of Participants With Disease Control at 12 Weeks
Time frame: At 12 Weeks
Time to Response (TTR)
Time frame: Until disease progression or data cut-off or Death (Up to 3.5 Years)
Progression Free Survival (PFS)
Time frame: Until disease progression or data cut-off or Death (Up to 3.5 Years)
Overall Survival (OS)
Time frame: Until disease progression or data cut-off or Death (Up to 3.5 Years)
Time to Maximum Concentration (Tmax)
Time frame: Cycle 1 (each cycle was 28 days in length) Day 1 (post-dose)
Maximum Concentration (Cmax)
Time frame: Cycle 1 (each cycle was 28 days in length) Day 1 (post-dose)
Partial Area Under the Concentration-time Curve (AUC0-6)
Time frame: Cycle 1 (each cycle was 28 days in length) Day 1 (post-dose) and Cycle 1 Day 7 (pre-dose and post-dose)
Area Under the Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t)
Time frame: Cycle 1 (each cycle was 28 days in length) Day 1 (post-dose) and Cycle 1 Day 7 (pre-dose and post-dose)
Time to Maximum Concentration at Steady State (Tmax,ss)
Time frame: Cycle 1 (each cycle was 28 days in length) Day 7 (pre-dose and post-dose)
Maximum Concentration at Steady State (Cmax,ss)
Time frame: Cycle 1 (each cycle was 28 days in length) Day 7 (pre-dose and post-dose)
Minimum Concentration at Steady State (Cmin,ss)
Time frame: Cycle 1 (each cycle was 28 days in length) Day 7 (pre-dose and post-dose)
Area Under the Concentration-time Curve at Steady State (AUCss)
Time frame: Cycle 1 (each cycle was 28 days in length) Day 7 (pre-dose and post-dose)
Apparent Clearance of Drug at Steady State at Steady State (CLss/F)
Time frame: Cycle 1 (each cycle was 28 days in length) Day 7 (pre-dose and post-dose)
Serum Concentrations of Durvalumab and Tremelimumab
Time frame: Durvalumab: Cycle 1 (each cycle was 4 weeks) Day 1(post-dose); Cycle 2 Day 1(pre-dose); Cycle 5 Day 1 (pre-dose); Tremelimumab: Cycle 1 (each cycle was 4 weeks) Day 1 (post-dose); Cycle 2 Day 1 (pre-dose); Cycle 5 Day 1 (No dose); Cycle 7 Day 1 (No dose)
Plasma Concentrations of Adavosertib and Carboplatin
Time frame: Adavosertib: Cycle 1 (each cycle was 21 days) Day 3 (pre-dose and post-dose); Cycle 3 Day 3 (pre-dose and post-dose); Carboplatin: Cycle 1 (each cycle was 21 days) Day 1 (post-dose)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 until disease progression, and follow-up visit (Up to 3.5 Years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- 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. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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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.
Haiyi Jiang, M.D. study director
AstraZeneca
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab and Tremelimumab, AZD1775 and carboplatin (CBPT) and AZD6738 and olaparib in people with Platinum Refractory Extensive-Stage Small Cell Lung Carcinoma, run by AstraZeneca at 12 sites in 5 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 9 inclusion and 23 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 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Hungary, Ukraine, Poland, Spain, Germany. 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 9 Sep 2021). 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?
Number of Participants With Overall Response (time frame: Until disease progression [PD] (Up to 3.5 Years)). 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 Jun 2024.