Study comparing tarlatamab with topotecan in patients with relapsed small cell lung cancer after first-line chemotherapy

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What is this study about?

This study focuses on treating Small Cell Lung Cancer (SCLC) that has returned after initial treatment with platinum-based chemotherapy. The study compares two treatment approaches: a new medication called tarlatamab versus standard care treatments that include topotecan, dexamethasone, tocilizumab, and siltuximab. The purpose is to determine if tarlatamab helps patients live longer compared to standard treatments.

Tarlatamab is given through an intravenous infusion, which means it is delivered directly into a vein. The standard care medications may be given either as infusions into a vein or as oral capsules, depending on the specific medication. During treatment, doctors will monitor how well the medications work and track any changes in the cancer.

Throughout the study, healthcare providers will assess various aspects of participants’ health, including chest pain, coughing, breathing difficulties, and overall well-being. They will also monitor how the disease responds to treatment and track how long participants survive after starting treatment. The study medication or standard care will be continued as long as it provides benefit to the participant and is well tolerated.

1 Initial screening and assignment

Your eligibility for the study will be evaluated based on specific criteria, including confirmation of small cell lung cancer that has returned or progressed after platinum-based treatment.

If eligible, you will be randomly assigned to receive either tarlatamab or standard care treatment.

2 Treatment administration

You will receive treatment through intravenous infusion (medication given directly into a vein).

The treatment will be either tarlatamab or one of the standard care medications (topotecan, dexamethasone, tocilizumab, or siltuximab).

The treatment will continue until your disease progresses or other stopping criteria are met.

3 Regular assessments

Your health status will be evaluated every 6 weeks for the first 18 weeks.

Assessments will include monitoring of chest pain, cough, chest tightness, and your overall physical function.

Regular scans will be performed to check if your disease has progressed.

4 Long-term follow-up

Your health status will continue to be monitored throughout the study period.

The study is expected to continue until March 2028.

Your participation will help evaluate how well tarlatamab works compared to standard treatments in extending survival time.

Who Can Join the Study?

  • Must be able to provide informed consent to participate in the study
  • Must be at least 18 years old or meet the legal adult age requirement in your country (whichever is higher)
  • Must have confirmed small cell lung cancer that has returned or worsened after previous treatment
  • Must have had disease progression or recurrence after receiving one platinum-based treatment (a specific type of chemotherapy)
  • Must have measurable disease that can be evaluated through imaging within 21 days before starting the study
  • Must have good physical functioning ability, scoring either 0 (fully active) or 1 (restricted in strenuous activity but able to carry out light work) on the ECOG scale
  • Must have a life expectancy of at least 12 weeks
  • Must have adequate organ function (meaning your major organs are working well enough to participate safely)

Who Cannot Join the Study?

  • Prior treatment with any DLL3-targeted therapy (a specific type of targeted cancer treatment)
  • Active brain metastases (cancer that has spread to the brain) that are untreated or unstable
  • History of another cancer within the past 3 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
  • Severe heart conditions, including:
    • Heart attack within the past 6 months
    • Unstable angina (chest pain)
    • Severe heart failure
  • Active, uncontrolled infections requiring systemic treatment
  • Known positive test for HIV, active hepatitis B, or active hepatitis C
  • Pregnant or breastfeeding women
  • Any serious medical condition that could interfere with study participation
  • Participation in another clinical trial within 30 days before starting this study
  • Known allergic reactions to similar medications used in this study
  • Significant psychiatric disorders that could affect ability to comply with the study protocol

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hospital Da Luz S.A. Lisbon Portugal
Semmelweis University Budapest Hungary
Hospital Del Mar Barcelona Spain
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Universitaetsklinikum Krems Krems An Der Donau Austria
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E. Lisbon Portugal
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
University Hospital Olomouc Olomouc Czechia
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
Hhzvlfnq Vqua dfosmdsc Barcelona Spain
Bccoemke Hkuemyhx Dublin Ireland
Hrhjqjk Pqohenqqliskchaz Rjhqbm Rennes France
Uxlzwxxxxa Hxxphnzt Cbbujdk Cologne Germany
Imbrqxhm Ryghwsxxx Pot Ld Soewcy Dkt Tigdws Dpwh Amyykmx Imuu Sbgmkn Meldola Italy
Aehfcowtru Pjizixbq Hpmougnv Dw Mreeqrkds Marseille France
Ubvuokfrjwep Mjhnbur Cqlwxyg Uvtqrpg Utrecht The Netherlands
Anfuvjxbg Hwvdygkv Athens Greece
Fgzsjzte Nndmagxyf Boog Brno Czechia
Etzkqgf Uhppcsyamuql Mcvjgtx Cqgolzf Rclzchwlg (krpmiah Mtj Rotterdam The Netherlands
Hiaifoti Uhlumduyvstrs Fwtezfwxg Jmkenin Dekx Madrid Spain
Ijltq Oqtxvxbq Pjpwkqkvuqq Smm Mzkfdun Genoa Italy
Jlglf Zukxrhupvo Hasselt Belgium
Akmioob Opdnuhvofnt Ulihlczmepwnr Focszocm It Dj Nbkuiv Naples Italy
Aaknaz Mquioho Cglggk Seba Thessaloniki Greece
Vyhysspfm Fwdeoqip Ntwvivwca V Przet Prague Czechia
Rrcrhdgkuujtmq Copenhagen Denmark
Hryioyzf Ds Lp Skrhq Cayp I Syqt Pmh Barcelona Spain
Ubksbjjpvkorxrnemistf Ebqrn Ark Essen Germany
Uzjaumlwjlhe Zjvskqeyln Glcy Gent Belgium
Afwmvmhhe Kbrwlx Gvkyvnz Gker Gauting Germany
Ubkisyadradt Mftgykj Cxaxshd Gnvrduupw Groningen The Netherlands
Dpjojveqs Hxqoxwcxyyx Bbcsjo Berlin Germany
Cxnfrl Himnebuqxol Liqn Sjz Pierre Benite France
Hghatmhx Usysxhuzfbomj Pcfhwa Dz Hnnjxx Dl Mnzmlefgsum Majadahonda Spain
Ahbzefco Zsfdjnuvxy Dcguo Roeselare Belgium
Afhjgdc Oyhrgygpeqg S Gmhuxglj Axulprhdex Rome Italy
Vwqsd Sint-Niklaas Belgium
Uudryuirxj Gxkxbui Hspjulim On Huymadkxv Heraklion Greece
Hindmdgp Cte Pbntm Synu Porto Portugal
Fwwgo Vbbkvtdzn Swfwl Gxmzuqp Ektqwbgs Obwkvr Kszdex Szekesfehervar Hungary
Mkgfqb Ghqovvsympoz Gyongyos Hungary
Awcvxpy Oaczzbrdjlj Oiqkpwfe Rhvarwr Vmqbn Siwjf Cgtkdsrs Palermo Italy
Lmy Hixqgmxa Ulrqiuygqrcqhh Da Skvopdhnuz STRASBOURG, Alsace France
Altwnmj Oeqzrjqhqtrifktlopfhghroe Sgh Lljoi Ghyrlat Orbassano Italy
Asojxoqhop Zcaiqkfnow Lkxgnt Leiden The Netherlands
Cakluhnk Gykdnjaxu Sqzbqq Bergamo Italy
Tpcmlvmxsspxoggxo Tnxsdnsgrtuus Torokbalint Hungary
Sgs Leahtcpelraj Hagjtfqf Spor Thessaloniki Greece
Uhjgnvnhurwmdsypynfue Wvzupokwy Azk Wuerzburg Germany
Wseaxphbjwgxd Cjmoeqj Prjbragonyim I Texwclqcrdfwrlc Irj Edcctam I Jxqnebj Zqkhawkbg Poznan Poland
Rfopzm Bcqri Kxtgpixaiqa Gpsx Stuttgart Germany
Nisjjwrnl Aptx Oagjquwxceoirlzxm abxs Ostrava Czechia
Srupt Sncixz Ovmmggdw Huexjmbd Athens Greece
Kcljykkaczjuhzksg Vxanrzary Slgex Busnlpc Klvwff Tatabanya Hungary
Hixpp Dclpqk Helsjpow Crjbfe Athens Greece
Ceyyhxh Pxahpihplwyu I Tejxiupyfigociz W Bbvntos Wilkowice Poland
Txrbmvdy Gztycbk Hiztjibm Oc Abyesi I Selznoo Athens Greece
Hbflfvpe Pqqtc Hpencfx Matosinhos Portugal
Iyficwhqyk Rkfdjpkh Db Oinciills Ikus Iasi Romania
Ctming Hlvlrceninm Ucgfomsksvdln Df Tfutxksp Toulouse France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
15.09.2023
Belgium Belgium
Not recruiting
15.09.2023
Czechia Czechia
Not recruiting
15.09.2023
Denmark Denmark
Not recruiting
15.09.2023
France France
Not recruiting
15.09.2023
Germany Germany
Not recruiting
15.09.2023
Greece Greece
Not recruiting
15.09.2023
Hungary Hungary
Not recruiting
15.09.2023
Ireland Ireland
Not recruiting
15.09.2023
Italy Italy
Not recruiting
15.09.2023
Poland Poland
Not recruiting
15.09.2023
Portugal Portugal
Not recruiting
15.09.2023
Romania Romania
Not recruiting
15.09.2023
Spain Spain
Not recruiting
15.09.2023
The Netherlands The Netherlands
Not recruiting
15.09.2023

Trial locations

Tarlatamab is an investigational medication being studied for treating small cell lung cancer in patients whose cancer has returned after initial platinum-based chemotherapy. It is a targeted therapy designed to find and attack cancer cells. The medication is being compared to standard treatments currently used for this type of cancer.

Standard of Care (SOC) refers to the current best available treatments that doctors typically use to treat small cell lung cancer after initial chemotherapy has failed. These may include various approved chemotherapy medications that are already established as treatment options for this condition.

Small Cell Lung Cancer (SCLC) – A fast-growing type of lung cancer that develops in the lungs’ small cells, typically in the bronchi. It is characterized by rapid cell division and early spread throughout the body. The cancer cells are smaller in size than most other types of lung cancer cells, which gives the disease its name. SCLC typically starts in the airways of the lungs and can spread quickly to other parts of the body. The condition often develops in people with a history of smoking.

Trial ID:
2022-502669-14-00
Protocol code:
20210004
NCT ID:
NCT05740566
Trial Phase:
Therapeutic confirmatory (Phase III)

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