Small cell lung cancer - null regimens

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The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main SCLC page for regimens that include active anticancer treatment.


Limited stage, consolidation after upfront therapy

Observation

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Jett et al. 1994 (NCCTG 86-20-51) 1987-1990 Phase 3 (C) IFN gamma Did not meet primary endpoint of OS
Kelly et al. 1995 (SWOG 8812) 1989-1991 Phase 3 (C) IFN alfa-2a Did not meet primary endpoint of OS
Giaccone et al. 2005 (Silva) 1998-2002 Phase 3 (C) Bec2 & BCG Did not meet primary endpoint of OS

No further treatment.

Preceding treatment

References

  1. NCCTG 86-20-51: Jett JR, Maksymiuk AW, Su JQ, Mailliard JA, Krook JE, Tschetter LK, Kardinal CG, Twito DI, Levitt R, Gerstner JB. Phase III trial of recombinant interferon gamma in complete responders with small-cell lung cancer. J Clin Oncol. 1994 Nov;12(11):2321-6. link to original article PubMed
  2. SWOG 8812: Kelly K, Crowley JJ, Bunn PA Jr, Hazuka MB, Beasley K, Upchurch C, Weiss GR, Hicks WJ, Gandara DR, Rivkin S, Livingston R. Role of recombinant interferon alfa-2a maintenance in patients with limited-stage small-cell lung cancer responding to concurrent chemoradiation: a Southwest Oncology Group study. J Clin Oncol. 1995 Dec;13(12):2924-30. link to original article PubMed
  3. Silva: Giaccone G, Debruyne C, Felip E, Chapman PB, Grant SC, Millward M, Thiberville L, D'addario G, Coens C, Rome LS, Zatloukal P, Masso O, Legrand C; EORTC. Phase III study of adjuvant vaccination with Bec2/bacille Calmette-Guerin in responding patients with limited-disease small-cell lung cancer (European Organisation for Research and Treatment of Cancer 08971-08971B; Silva Study). J Clin Oncol. 2005 Oct 1;23(28):6854-64. link to original article PubMed NCT00037713

Placebo

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Awaiting publication (ADRIATIC) 2018-ongoing Phase 3 (C) 1. Durvalumab
2. Durvalumab & Tremelimumab 		In progress
Awaiting publication (KEYLYNK-013) 2020-ongoing Phase 3 (C) 1. Pembrolizumab
2. Olaparib & Pembrolizumab 		In progress

No further antineoplastic treatment.

References

  1. ADRIATIC: NCT03703297
  2. KEYLYNK-013: NCT04624204

Extensive stage, maintenance after first-line therapy

Observation

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Jett et al. 1994 (NCCTG 86-20-51) 1987-1990 Phase 3 (C) IFN gamma Did not meet primary endpoint of OS
van Zandwijk et al. 1997 (EORTC 0883) 1989-1993 Phase 3 (C) IFN gamma Did not meet primary endpoint of OS
Hanna et al. 2002 1993-1998 Phase 3 (C) Etoposide Might have inferior OS
Schiller et al. 2001 (ECOG E7593) 1995-1999 Phase 3 (C) Topotecan Did not meet primary endpoint of OS50%
Ready et al. 2015 (CALGB 30504) 2007-2011 Randomized Phase 2 (C) Sunitinib Seems to have inferior PFS
Santo et al. 2019 (G04.2011) 2012-2016 Phase 3 (C) Lanreotide Did not meet primary endpoint of PFS
Median PFS: 2.3 vs 3.6 mo
(HR 1.51, 95% CI 0.90-2.50)

No further treatment.

Biomarker eligibility criteria

  • G04.2011: Somatostatin receptor positivity at diagnosis

Preceding treatment

References

  1. NCCTG 86-20-51: Jett JR, Maksymiuk AW, Su JQ, Mailliard JA, Krook JE, Tschetter LK, Kardinal CG, Twito DI, Levitt R, Gerstner JB. Phase III trial of recombinant interferon gamma in complete responders with small-cell lung cancer. J Clin Oncol. 1994 Nov;12(11):2321-6. link to original article PubMed
  2. EORTC 0883: van Zandwijk N, Groen HJ, Postmus PE, Burghouts JT, ten Velde GP, Ardizzoni A, Smith IE, Baas P, Sahmoud T, Kirkpatrick A, Dalesio O, Giaccone G; EORTC Lung Cancer Cooperative Group. Role of recombinant interferon-gamma maintenance in responding patients with small cell lung cancer: a randomised phase III study of the EORTC Lung Cancer Cooperative Group. Eur J Cancer. 1997 Oct;33(11):1759-66. link to original article PubMed
  3. ECOG E7593: Schiller JH, Adak S, Cella D, DeVore RF 3rd, Johnson DH. Topotecan versus observation after cisplatin plus etoposide in extensive-stage small-cell lung cancer: E7593--a phase III trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2001 Apr 15;19(8):2114-22. link to original article PubMed
  4. Hanna NH, Sandier AB, Loehrer PJ Sr, Ansari R, Jung SH, Lane K, Einhorn LH. Maintenance daily oral etoposide versus no further therapy following induction chemotherapy with etoposide plus ifosfamide plus cisplatin in extensive small-cell lung cancer: a Hoosier Oncology Group randomized study. Ann Oncol. 2002 Jan;13(1):95-102. link to original article PubMed
  5. CALGB 30504: Ready NE, Pang HH, Gu L, Otterson GA, Thomas SP, Miller AA, Baggstrom M, Masters GA, Graziano SL, Crawford J, Bogart J, Vokes EE. Chemotherapy with or without maintenance sunitinib for untreated extensive-stage small-cell lung cancer: A randomized, double-blind, placebo-controlled phase II study-CALGB 30504 (Alliance). J Clin Oncol. 2015 May 20;33(15):1660-5. Epub 2015 Mar 2. link to original article link to PMC article PubMed NCT00453154
  6. G04.2011: Santo A, Pilotto S, Galetta D, Grossi F, Fasola G, Romano G, Bonanno L, Bearz A, Papi M, Roca E, Catino A, Follador A, Rijavec E, Genova C, Petrillo P, Favaretto A, Giannone L, Milella M, Tortora G, Giannarelli D, Bria E; Italian association FONICAP (Operative National Interdisciplinary Force against Lung Cancer). Maintenance with lanreotide in small-cell lung cancer expressing somatostatine receptors: A multicenter, randomized, phase 3 trial. Lung Cancer. 2019 Aug;134:121-126. Epub 2019 Jun 11. link to original article PubMed EudraCT 2011-005730-20

Placebo

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Shepherd et al. 2002 (NCIC-CTG BR.12) 1997-2000 Phase 3 (C) Marimastat Did not meet primary endpoint of OS
Owonikoko et al. 2021 (CheckMate 451) 2015-2018 Phase 3 (C) 1. Ipilimumab & Nivolumab Did not meet primary endpoint of OS
Median OS: 9.6 vs 9.2 mo
(HR 1.09, 95% CI 0.89-1.33)
2. Nivolumab Might have inferior OS
Median OS: 9.6 vs 10.4 mo
(HR 1.19, 95% CI 0.98-1.45)
Johnson et al. 2021 (MERU) 2017-2019 Phase 3 (C) Rovalpituzumab tesirine Did not meet primary endpoint of OS
Ai et al. 2021 (ZL-2306-005) 2018-2020 Phase 3 (C) Niraparib Did not meet primary endpoint of OS
Median OS: 11.4 vs 9.9 mo
(HR 0.97, 95% CI 0.58-1.61)

No further antineoplastic treatment.

Preceding treatment

References

  1. NCIC-CTG BR.12: Shepherd FA, Giaccone G, Seymour L, Debruyne C, Bezjak A, Hirsh V, Smylie M, Rubin S, Martins H, Lamont A, Krzakowski M, Sadura A, Zee B; NCIC-CTG; EORTC. Prospective, randomized, double-blind, placebo-controlled trial of marimastat after response to first-line chemotherapy in patients with small-cell lung cancer: a trial of the National Cancer Institute of Canada-Clinical Trials Group and the European Organisation for Research and Treatment of Cancer. J Clin Oncol. 2002 Nov 15;20(22):4434-9. link to original article PubMed NCT00003011
  2. CheckMate 451: Owonikoko TK, Park K, Govindan R, Ready N, Reck M, Peters S, Dakhil SR, Navarro A, Rodríguez-Cid J, Schenker M, Lee JS, Gutierrez V, Percent I, Morgensztern D, Barrios CH, Greillier L, Baka S, Patel M, Lin WH, Selvaggi G, Baudelet C, Baden J, Pandya D, Doshi P, Kim HR. Nivolumab and Ipilimumab as Maintenance Therapy in Extensive-Disease Small-Cell Lung Cancer: CheckMate 451. J Clin Oncol. 2021 Apr 20;39(12):1349-1359. Epub 2021 Mar 8. link to original article link to PMC article PubMed NCT02538666
  3. ZL-2306-005: Ai X, Pan Y, Shi J, Yang N, Liu C, Zhou J, Zhang X, Dong X, He J, Li X, Chen G, Li X, Zhang H, Liao W, Zhang Y, Ma Z, Jiang L, Cui J, Hu C, Wang W, Huang C, Zhao J, Ding C, Hu X, Wang K, Gao B, Song Y, Liu X, Xiong J, Liu A, Li J, Liu Z, Li Y, Wang M, Zhang B, Zhang D, Lu S. Efficacy and Safety of Niraparib as Maintenance Treatment in Patients With Extensive-Stage SCLC After First-Line Chemotherapy: A Randomized, Double-Blind, Phase 3 Study. J Thorac Oncol. 2021 Aug;16(8):1403-1414. Epub 2021 Apr 26. link to original article PubMed NCT03516084
  4. MERU: Johnson ML, Zvirbule Z, Laktionov K, Helland A, Cho BC, Gutierrez V, Colinet B, Lena H, Wolf M, Gottfried M, Okamoto I, van der Leest C, Rich P, Hung JY, Appenzeller C, Sun Z, Maag D, Luo Y, Nickner C, Vajikova A, Komarnitsky P, Bar J. Rovalpituzumab Tesirine as a Maintenance Therapy After First-Line Platinum-Based Chemotherapy in Patients With Extensive-Stage-SCLC: Results From the Phase 3 MERU Study. J Thorac Oncol. 2021 Sep;16(9):1570-1581. Epub 2021 Apr 3. link to original article PubMed NCT03033511

Relapsed or refractory disease

Best supportive care

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
O'Brien et al. 2006 (GSK 104864/478) 2000-2004 Phase 3 (C) Oral topotecan Seems to have inferior OS

No active antineoplastic treatment.

References

  1. GSK 104864/478: O'Brien ME, Ciuleanu TE, Tsekov H, Shparyk Y, Cuceviá B, Juhasz G, Thatcher N, Ross GA, Dane GC, Crofts T. Phase III trial comparing supportive care alone with supportive care with oral topotecan in patients with relapsed small-cell lung cancer. J Clin Oncol. 2006 Dec 1;24(34):5441-7. link to original article PubMed NCT00276276
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