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ATLANTIS

Combination lurbinectedin and doxorubicin versus physician's choice of chemotherapy in patients with relapsed small-cell lung cancer

Phase 3N = 613NCT02566993

Population
Adults with small-cell lung cancer that relapsed after platinum-based chemotherapy
Design
Open-label randomised (1:1) phase 3 trial at 135 hospitals; lurbinectedin 2.0 mg/m2 plus doxorubicin 40.0 mg/m2 on day 1 of 21-day cycles versus physician's choice of topotecan (n=127) or cyclophosphamide, doxorubicin and vincristine (CAV; n=179); primary G-CSF prophylaxis mandatory. Primary endpoint OS in the ITT population; outcomes assessed by an independent review committee masked to allocation.
Primary endpoint
OS
Arms
  • Lurbinectedin plus doxorubicin (experimental, n = 307): Lurbinectedin 2.0 mg/m2 plus doxorubicin 40.0 mg/m2 on day 1 of 21-day cycles
  • Physician's choice (control): Topotecan 1.5 mg/m2 on days 1-5, or CAV (cyclophosphamide 1000 mg/m2, doxorubicin 45.0 mg/m2, vincristine 2.0 mg) on day 1, of 21-day cycles
People
Aix SP, senior author Paz-Ares L
OSHR 0.97 (95% CI 0.82–1.15)Δ median OS+1 months
Show the numbers
Results reported for ATLANTIS
EndpointAnalysisLurbinectedin plus doxorubicinPhysician's choiceEffect
OSprimarymedian follow-up 24.1 monthsAix 2023median 8.6 months (7.1–9.4)median 7.6 months (6.6–8.2)HR 0.97 (95% CI 0.82–1.15)P=0.90The p value shown is the stratified log-rank test; p=0.70 is reported for the hazard ratio. The authors conclude the combination did not improve OS versus control.
Results reported for ATLANTIS
EndpointAnalysisLurbinectedin plus doxorubicinPhysician's choiceEffect
OSprimarymedian follow-up 24.1 monthsAix 2023median 8.6 months (7.1–9.4)median 7.6 months (6.6–8.2)HR 0.97 (95% CI 0.82–1.15)P=0.90The p value shown is the stratified log-rank test; p=0.70 is reported for the hazard ratio. The authors conclude the combination did not improve OS versus control.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.970.82–1.15
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Lurbinectedin plus doxorubicin (experimental)
  • Physician's choice (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsLurbinectedin plus doxorubicinPhysician's choice
0100.0%100.0%
566.8%63.4%
1141.2%36.7%
1627.5%23.2%
2217.0%13.4%
Primary publication: Aix SP, Ciuleanu TE, Navarro A, Cousin S, Bonanno L, Smit EF, et al. Combination lurbinectedin and doxorubicin versus physician's choice of chemotherapy in patients with relapsed small-cell lung cancer (ATLANTIS): a multicentre, randomised, open-label, phase 3 trial. Lancet Respir Med. 2023;11(1):74-86. PubMedDOI

Appears in

Sources

  1. Aix SP, Ciuleanu TE, Navarro A, Cousin S, Bonanno L, Smit EF, et al. Combination lurbinectedin and doxorubicin versus physician's choice of chemotherapy in patients with relapsed small-cell lung cancer (ATLANTIS): a multicentre, randomised, open-label, phase 3 trial. Lancet Respir Med. 2023;11(1):74-86.

    PubMedDOI