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NCT Number: NCT05361395

First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

This is a phase 1b study to assess the safety and tolerability of tarlatamab in combination with programmed death ligand (PD-L1) inhibition with and without chemotherapy.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chris OBrien Lifehouse, Camperdown, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant has provided informed consent prior to initiation of any study specific activities/procedures.
  • Age greater than or equal to 18 years old at the same time of signing the informed consent.
  • Histologically or cytologically confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC) and no prior systemic treatment for ES-SCLC.
  • Participants with prior treatment for limited-stage SCLC (LS-SCLC) are permitted.
  • Eastern Cooperative Oncology Group (ECOG) 0 to 1.
  • Participants with treated asymptomatic brain metastases are eligible provided they meet defined criteria.
  • Adequate organ function as defined in protocol.

Exclusion criteria

  • History of other malignancy within the past 2 years with exceptions.
  • Major surgery within 28 days of study day 1.
  • Untreated or symptomatic brain metastases and leptomeningeal disease.
  • Participants who experienced recurrent grade 2 pneumonitis or severe or life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
  • History of immune-related colitis.
  • History or evidence of interstitial lung disease or active, non-infectious pneumonitis.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
  • Participants with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment
  • Participant has known active infection requiring parenteral antibiotic treatment. Upon completion of parenteral antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint
  • NOTE: Simple urinary tract infections and uncomplicated bacterial pharyngitis are permitted if responding to an active treatment and after consultation with Medical Monitor. Participants requiring oral antibiotics who have been afebrile for >24 hours, have no leukocytosis, nor clinical signs of infection are eligible. Screening for chronic infectious conditions is not required.
  • History of hypophysitis or pituitary dysfunction.
  • History of solid organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. Participants with Type I diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted.

Treatment and study plan

Tarlatamab

Drug

Tarlatamab will be administered as an intravenous (IV) infusion.

Other names: AMG 757

carboplatin

Drug

Carboplatin will be administered as an intravenous (IV) infusion.

etoposide

Drug

Etoposide will be administered as an intravenous (IV) infusion.

Atezolizumab

Drug

Atezolizumab will be administered as an intravenous (IV) infusion.

Other names: Tecentriq

Durvalumab

Drug

Durvalumab will be administered as an intravenous (IV) infusion.

Primary outcomes

  1. Number of Participants with a Dose Limiting Toxicity (DLT)

    Time frame: 24 months

  2. Number of Participants with Treatment-emergent Adverse Events (TEAE)

    Time frame: 24 months

  3. Number of Participants with Treatment-related Adverse Events

    Time frame: 24 months

  4. Number of Participants with Clinically Significant Changes in Vital Signs

    Time frame: 24 months

  5. Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements

    Time frame: 24 months

  6. Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests

    Time frame: 24 months

Secondary outcomes

  1. 6-month Progression-free Survival (PFS)

    Time frame: 24 months

  2. Objective Response (OR)

    Time frame: 24 months

    Per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

  3. Duration of Response (DOR)

    Time frame: 24 months

  4. Disease Control Rate(DCR)

    Time frame: 24 months

  5. Overall Survival (OS)

    Time frame: 24 months

  6. Serum Concentration of Tarlatamab

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Phase 1b Study Evaluating the Safety and Efficacy of First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung (DeLLphi-303)

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
May 4, 2022
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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