Trial · NCT03164616
Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON).
NCT03164616, Phase 3, Active not recruiting, AstraZeneca; results first posted 2022-04-07
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON). Trials, record NCT03164616. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03164616
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON).
- NCT number
- NCT03164616
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 1,186 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Non Small Cell Lung Cancer NSCLC
- Interventions
- Durvalumab, Tremelimumab, Abraxane + carboplatin, Gemcitabine + cisplatin, Gemcitabine + carboplatin, Pemetrexed + carboplatin, Pemetrexed + cisplatin
- First posted
- 2017-05-23
- Last updated
- 2026-03-13
- Other registries' IDs
- eudract:2017-000920-81
- Results first posted
- 2022-04-07
- Limitations and caveats
This study also incorporates a China tail, comprising additional patients randomized after the end of the global cohort recruitment. Efficacy and safety of patients randomized in China will be reported at a later date once this separate analysis has been completed.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS); D + SoC Compared With SoC Alone | Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months). | PFS (per RECIST version 1.1 \[RECIST 1.1\] using Blinded Independent Central Review \[BICR\] assessments) was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Median PFS was calculated using the Kaplan-Meier technique. The final analysis of PFS in the global cohort was pre-specified after approximately 497 BICR PFS events occurred across the D + SoC and SoC alone treatment arms (75% maturity). |
| Primary | Overall Survival (OS); D + SoC Compared With SoC Alone | From baseline until death due to any cause. Assessed until global cohort DCO of 12 March 2021 (maximum of approximately 45 months). | OS was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. The final analysis of OS in the global cohort was pre-specified after approximately 532 OS events occurred across the D + SoC and SoC alone treatment arms (80% maturity). |
| Secondary | PFS; T + D + SoC Compared With SoC Alone and T + D + SoC Compared With D + SoC | Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months. | PFS (per RECIST 1.1 using BICR assessments) was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Median PFS was calculated using the Kaplan-Meier technique. |
| Secondary | OS; T + D + SoC Compared With SoC Alone and T + D + SoC Compared With D + SoC | From baseline until death due to any cause. Assessed until global cohort DCO of 12 March 2021 (maximum of approximately 45 months). | OS was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. |
| Secondary | Objective Response Rate (ORR) | Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months). | ORR (per RECIST 1.1 using BICR assessments) was defined as the percentage of patients with at least one visit response of complete response (CR) or partial response (PR). Results are presented for the pre-specified ORR analysis using unconfirmed responses based on BICR. |
| Secondary | Best Objective Response (BoR) | Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months). | The BoR was calculated based on the overall visit responses from each RECIST 1.1 assessment. BOR was defined as the best response a patient had following randomization, but prior to starting any subsequent cancer therapy and up to and including RECIST 1.1 progression or the last evaluable assessment in the absence of RECIST 1.1 progression, as determined by BICR. Categorization of BoR was based on RECIST using the following 'response' categories: CR and PR and the following 'non-response' categories: stable disease (SD) ≥6 weeks, progression (ie, PD) and not evaluable (NE). Results are presented for number (%) of patients in each specified category. |
| Secondary | Duration of Response (DoR) | Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months). | DoR (per RECIST 1.1 using BICR assessments) was defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression. The end of response coincided with the date of progression or death from any cause used for the RECIST 1.1 PFS endpoint. The time of the initial response was defined as the latest of the dates contributing towards the first visit of PR or CR. Results are presented for the pre-specified DoR analysis using unconfirmed responses based on BICR. |
| Secondary | Time From Randomization to Second Progression (PFS2) | Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months). | PFS2 was defined as the time from the date of randomization to the earliest of the progression event (subsequent to that used for the primary variable PFS) or death. The date of second progression was recorded by the Investigator and defined according to local standard clinical practice and could involve any of: objective radiological imaging, symptomatic progression or death. |
| Secondary | Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations | Samples were collected post-dose on Day 1 (Week 0), pre-dose on Weeks 3 and 12 and at follow-up (3 months after the last valid dose). Assessed at the global cohort DCO of 12 March 2021. | To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of durvalumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively. |
| Secondary | PK of Tremelimumab; Peak and Trough Serum Concentrations | Samples were collected post-dose on Day 1 (Week 0), pre-dose on Weeks 3 and 12 and at follow-up (3 months after the last valid dose). Assessed at the global cohort DCO of 12 March 2021. | To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of tremelimumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS); D + SoC Compared With SoC Alone | Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months). | Global cohort: The FAS included all randomized patients. Analysis of PFS was assessed as a primary outcome measure for comparison of the D + SoC vs SoC alone treatment arms only. The alternative treatment arm comparisons were assessed as a secondary outcome measure. | months | MEDIAN |
| PRIMARY | Overall Survival (OS); D + SoC Compared With SoC Alone | From baseline until death due to any cause. Assessed until global cohort DCO of 12 March 2021 (maximum of approximately 45 months). | Global cohort: The FAS included all randomized patients. Analysis of OS was assessed as a primary outcome measure for comparison of the D + SoC vs SoC alone treatment arms only. The alternative treatment arm comparisons were assessed as a secondary outcome measure. | months | MEDIAN |
| SECONDARY | PFS; T + D + SoC Compared With SoC Alone and T + D + SoC Compared With D + SoC | Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months. | Global cohort: The FAS included all randomized patients. | months | MEDIAN |
| SECONDARY | OS; T + D + SoC Compared With SoC Alone and T + D + SoC Compared With D + SoC | From baseline until death due to any cause. Assessed until global cohort DCO of 12 March 2021 (maximum of approximately 45 months). | Global cohort: The FAS included all randomized patients. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months). | Global cohort: The FAS included all randomized patients. The denominator was a subset of the FAS who had measurable disease at baseline. | percentage of patients | NUMBER |
| SECONDARY | Best Objective Response (BoR) | Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months). | Global cohort: The FAS included all randomized patients. The denominator was a subset of the FAS who had measurable disease at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DoR) | Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months). | Global cohort: The FAS included all randomized patients. Only patients with an objective response were included in the analysis. | months | MEDIAN |
| SECONDARY | Time From Randomization to Second Progression (PFS2) | Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months). | Global cohort: The FAS included all randomized patients. | months | MEDIAN |
| SECONDARY | Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations | Samples were collected post-dose on Day 1 (Week 0), pre-dose on Weeks 3 and 12 and at follow-up (3 months after the last valid dose). Assessed at the global cohort DCO of 12 March 2021. | Global cohort: The PK analysis set included all patients who received at least 1 dose of durvalumab or tremelimumab per the protocol for whom any post-dose PK data were available and without any protocol deviations that would significantly affect the PK analyses. PK for durvalumab was performed for the T + D + SoC and D + SoC treatment arms only. | micrograms/milliliter (μg/mL) | GEOMETRIC_MEAN |
| SECONDARY | PK of Tremelimumab; Peak and Trough Serum Concentrations | Samples were collected post-dose on Day 1 (Week 0), pre-dose on Weeks 3 and 12 and at follow-up (3 months after the last valid dose). Assessed at the global cohort DCO of 12 March 2021. | Global cohort: The PK analysis set included all patients who received at least 1 dose of durvalumab or tremelimumab per the protocol for whom any post-dose PK data were available and without any protocol deviations that would significantly affect the PK analyses. PK for tremelimumab was performed for the T + D + SoC treatment arm only. | μg/mL | GEOMETRIC_MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group133
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS); D + SoC Compared With SoC Alone | D + SoC | 5.5 | 95% Confidence Interval 4.7 to 6.5 | months | |
| Progression-Free Survival (PFS); D + SoC Compared With SoC Alone | SoC Alone | 4.8 | 95% Confidence Interval 4.6 to 5.8 | months | |
| Overall Survival (OS); D + SoC Compared With SoC Alone | D + SoC | 13.3 | 95% Confidence Interval 11.4 to 14.7 | months | |
| Overall Survival (OS); D + SoC Compared With SoC Alone | SoC Alone | 11.7 | 95% Confidence Interval 10.5 to 13.1 | months | |
| PFS; T + D + SoC Compared With SoC Alone and T + D + SoC Compared With D + SoC | T + D + SoC | 6.2 | 95% Confidence Interval 5.0 to 6.5 | months | |
| PFS; T + D + SoC Compared With SoC Alone and T + D + SoC Compared With D + SoC | D + SoC | 5.5 | 95% Confidence Interval 4.7 to 6.5 | months | |
| PFS; T + D + SoC Compared With SoC Alone and T + D + SoC Compared With D + SoC | SoC Alone | 4.8 | 95% Confidence Interval 4.6 to 5.8 | months | |
| OS; T + D + SoC Compared With SoC Alone and T + D + SoC Compared With D + SoC | T + D + SoC | 14.0 | 95% Confidence Interval 11.7 to 16.1 | months | |
| OS; T + D + SoC Compared With SoC Alone and T + D + SoC Compared With D + SoC | D + SoC | 13.3 | 95% Confidence Interval 11.4 to 14.7 | months | |
| OS; T + D + SoC Compared With SoC Alone and T + D + SoC Compared With D + SoC | SoC Alone | 11.7 | 95% Confidence Interval 10.5 to 13.1 | months |
1 to 10 of 133Source ClinicalTrials.gov
See all 133 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | T + D + SoC | 338 | |
| Overall Study | STARTED | D + SoC | 338 | |
| Overall Study | STARTED | SoC Alone | 337 | |
| Overall Study | Received Treatment | T + D + SoC | 331 | |
| Overall Study | Received Treatment | D + SoC | 335 | |
| Overall Study | Received Treatment | SoC Alone | 331 | |
| Overall Study | COMPLETED | T + D + SoC | 80 | |
| Overall Study | COMPLETED | D + SoC | 65 | |
| Overall Study | COMPLETED | SoC Alone | 40 | |
| Overall Study | NOT COMPLETED | T + D + SoC | 258 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events879
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | T + D + SoC | 19 | 330 | 22 |
| other | Abdominal pain | Gastrointestinal disorders | D + SoC | 16 | 334 | 19 |
| other | Abdominal pain | Gastrointestinal disorders | SoC Alone | 10 | 333 | 10 |
| other | Constipation | Gastrointestinal disorders | T + D + SoC | 63 | 330 | 85 |
| other | Constipation | Gastrointestinal disorders | D + SoC | 72 | 334 | 98 |
| other | Constipation | Gastrointestinal disorders | SoC Alone | 79 | 333 | 96 |
| other | Diarrhoea | Gastrointestinal disorders | T + D + SoC | 65 | 330 | 98 |
| other | Diarrhoea | Gastrointestinal disorders | D + SoC | 57 | 334 | 72 |
| other | Diarrhoea | Gastrointestinal disorders | SoC Alone | 49 | 333 | 66 |
| other | Leukopenia | Blood and lymphatic system disorders | T + D + SoC | 41 | 330 | 80 |
1 to 10 of 879Source ClinicalTrials.gov
See all 879 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | T + D + SoC | 251 | 338 |
| Total, all-cause mortality | D + SoC | 265 | 338 |
| Total, all-cause mortality | SoC Alone | 285 | 337 |
| Total, other adverse events | T + D + SoC | 309 | 330 |
| Total, other adverse events | D + SoC | 302 | 334 |
| Total, other adverse events | SoC Alone | 301 | 333 |
| Total, serious adverse events | T + D + SoC | 146 | 330 |
| Total, serious adverse events | D + SoC | 134 | 334 |
| Total, serious adverse events | SoC Alone | 117 | 333 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03164616
GET https://conductscience.org/api/trials/v1/NCT03164616/results?page=2