Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer

Summary

Phase III randomized clinical trial of lurbinectedin (PM01183)/doxorubicin (DOX) versus cyclophosphamide (CTX), doxorubicin (DOX) and vincristine (VCR) (CAV) or topotecan as treatment in patients with small-cell lung cancer (SCLC) who failed one prior platinum-containing line.

Timeline

Start

2016-08-30

Primary completion

2020-02-24

Completion

2020-02-24

Outcome

Missed primary endpoint

paper stratified log-rank p=0·90; hazard ratio 0·97 [95% CI 0·82-1·15], p=0·70. PMID 36252599 ↗

paper Combination therapy with lurbinectedin plus doxorubicin did not improve overall survival versus control in patients with relapsed SCLC. PMID 36252599 ↗

release “While the combination of lurbinectedin and doxorubicin did not achieve the primary endpoint in this study” jazzpharma.com ↗

Publications

• Aix SP, Ciuleanu TE, Navarro A, Cousin S, Bonanno L, Smit EF, Chiappori A, Olmedo ME, Horvath I, Grohe C, Farago AF, Lopez-Vilarino JA, Cullell-Young M, Nieto A, Vasco N, Gomez J, Kahatt C, Zeaiter A, Carcereny E, Roubec J, Syrigos K, Lo G, Barneto I, Pope A, Sanchez A, Kattan J, Zarogoulidis K, Waller CF, Bischoff H, Juan-Vidal O, Reinmuth N, Domine M, Paz-Ares L. 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 Jan;11(1):74-86. doi: 10.1016/S2213-2600(22)00309-5. Epub 2022 Oct 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cyclophosphamide	Other / unclassified	1000 mg/m2	Intravenous
Subject	Doxorubicin	Other / unclassified	40 mg/m2	Intravenous
Subject	Doxorubicin	Other / unclassified	45 mg/m2	Intravenous
Subject	Lurbinectedin	Other / unclassified	2 mg/m2	Intravenous
Comparator	Topotecan	Small molecule	1.5 mg/m2	Intravenous
Comparator	Vincristine	Small molecule	2 mg	Intravenous

Indications