Authorised Therapeutic exploratory (Phase II) Relapsed/Refractory Small Cell Lung Cancer

A Phase 2 Study of Tarlatamab in Patients with Small Cell Lung Cancer (SCLC).

EU CTIS ID: 2024-511837-37-00

What this study is testing

Part 1 only To evaluate safety and efficacy (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] by investigator) of 2 dose levels of tarlatamab. Parts 1 and 2 Evaluate anti-tumor activity of tarlatamab as determined by objective response rate (ORR) per RECIST 1.1 by blinded independent central review (BICR) Part 3 Evaluate safety of reduced mandatory monitoring period in cycle 1 at selected dose of tarlatamab

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 101 Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures.
  • 110 Adequate organ function, defined as follows: hematological function: - absolute neutrophil count >= 1 x 10^9/L - platelet count >= 100 x 10^9/L - hemoglobin > 9 g/dL (90 g/L) coagulation function: - prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) <= 1.5 x institutional upper limit of normal (ULN). Subjects on chronic anticoagulation therapy who do not meet the criteria above may be eligible to enroll after discussion with the medical monitor. renal function: - estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculation > 30 mL/min/1.73 m2 hepatic function: - aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) < 3 X ULN (or < 5 X ULN for subjects with liver involvement) - total bilirubin < 1.5 X ULN (or < 2 X ULN for subjects with liver metastases). pulmonary function: - no clinically significant pleural effusion - baseline oxygen saturation > 90% on room air cardiac function: - cardiac ejection fraction >= 50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no clinically significant electrocardiogram (ECG) findings
  • 102 Male and female subjects >= 18 years of age (or legal adult age within country) at the time of signing the informed consent.
  • 103 Histologically or cytologically confirmed relapsed/refractory SCLC
  • 104 Subjects who progressed or recurred following 1 platinum-based regimen and at least 1 other prior line of therapy Note: (1) re-treatment with a platinum-based regimen is considered a second line of therapy; (2) platinum-based regimen followed by checkpoint inhibitor/anti-programmed death ligand 1 (PD-L1) as maintenance therapy is considered 1 line of therapy; (3) in countries where standard of care first line systemic treatment includes platinum containing chemotherapy in combination with PD-L1 inhibitor, it is required that patients have failed PD-L1 inhibitor as part of their first line systemic treatment or are ineligible to receive PD-L1 inhibitor therapy.
  • 105 Subjects willing to provide archived tumor tissue samples (formalin fixed, paraffin embedded [FFPE] sample) or willing to undergo pretreatment tumor biopsy. Subjects who do not have archived tumor tissue available and are unable to undergo a pretreatment tumor biopsy due to extenuating circumstances (eg, cannot be performed safely or inaccessible, as determined by the investigator) may be allowed to enroll without a tumor biopsy upon agreement between the investigator and Amgen medical monitor.

You likely can't join if

  • 201 Untreated or symptomatic brain metastases and leptomeningeal disease.
  • 204 Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1, or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible(defined as having been present and stable for > 21 days) which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen.
  • 205 History of other malignancy within the past 2 years, with the following exceptions: - malignancy treated with curative intent and with no known active disease present for >= 2 years before enrollment and felt to be at low risk for recurrence by the treating physician. - adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. - adequately treated cervical carcinoma in situ without evidence of disease. - adequately treated breast ductal carcinoma in situ without evidence of disease. - prostatic intraepithelial neoplasia without evidence of prostate cancer. - adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
  • 206 Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of Tarlatamab (Section 11.9).
  • 207 History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of first dose of Tarlatamab.
  • 208 Subject 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 Tarlatamab. NOTE: Simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor. Subjects requiring oral antibiotics who have been afebrile > 24 hours, have no leukocytosis and have no clinical signs of infection are eligible. Subjects who meet these criteria and who were previously on IV antimicrobials should have been off IV antimicrobials for > 48 hours.
See the full eligibility criteria
Who can join
  • 101 Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures.
  • 110 Adequate organ function, defined as follows: hematological function: - absolute neutrophil count >= 1 x 10^9/L - platelet count >= 100 x 10^9/L - hemoglobin > 9 g/dL (90 g/L) coagulation function: - prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) <= 1.5 x institutional upper limit of normal (ULN). Subjects on chronic anticoagulation therapy who do not meet the criteria above may be eligible to enroll after discussion with the medical monitor. renal function: - estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculation > 30 mL/min/1.73 m2 hepatic function: - aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) < 3 X ULN (or < 5 X ULN for subjects with liver involvement) - total bilirubin < 1.5 X ULN (or < 2 X ULN for subjects with liver metastases). pulmonary function: - no clinically significant pleural effusion - baseline oxygen saturation > 90% on room air cardiac function: - cardiac ejection fraction >= 50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no clinically significant electrocardiogram (ECG) findings
  • 102 Male and female subjects >= 18 years of age (or legal adult age within country) at the time of signing the informed consent.
  • 103 Histologically or cytologically confirmed relapsed/refractory SCLC
  • 104 Subjects who progressed or recurred following 1 platinum-based regimen and at least 1 other prior line of therapy Note: (1) re-treatment with a platinum-based regimen is considered a second line of therapy; (2) platinum-based regimen followed by checkpoint inhibitor/anti-programmed death ligand 1 (PD-L1) as maintenance therapy is considered 1 line of therapy; (3) in countries where standard of care first line systemic treatment includes platinum containing chemotherapy in combination with PD-L1 inhibitor, it is required that patients have failed PD-L1 inhibitor as part of their first line systemic treatment or are ineligible to receive PD-L1 inhibitor therapy.
  • 105 Subjects willing to provide archived tumor tissue samples (formalin fixed, paraffin embedded [FFPE] sample) or willing to undergo pretreatment tumor biopsy. Subjects who do not have archived tumor tissue available and are unable to undergo a pretreatment tumor biopsy due to extenuating circumstances (eg, cannot be performed safely or inaccessible, as determined by the investigator) may be allowed to enroll without a tumor biopsy upon agreement between the investigator and Amgen medical monitor.
  • 106 Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • 107 Minimum life expectancy of 12 weeks.
  • 108 Measurable lesions as defined per RECIST 1.1 within 21 days prior to the first dose of Tarlatamab.
  • 109 Subjects with treated brain metastases are eligible provided they meet the following criteria: - Definitive therapy was completed at least 2 weeks prior to the first dose of Tarlatamab. - There is no evidence of radiographic central nervous system (CNS) progression following definitive therapy and by the time of study screening. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means and after discussion with the medical monitor. - Any CNS disease is asymptomatic for at least 7 days (unless symptoms are deemed irreversible by the investigator), the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the subject is off or on stable doses of anti-epileptic drugs for malignant CNS disease for at least 7 days.
What rules you out
  • 201 Untreated or symptomatic brain metastases and leptomeningeal disease.
  • 204 Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1, or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible(defined as having been present and stable for > 21 days) which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen.
  • 205 History of other malignancy within the past 2 years, with the following exceptions: - malignancy treated with curative intent and with no known active disease present for >= 2 years before enrollment and felt to be at low risk for recurrence by the treating physician. - adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. - adequately treated cervical carcinoma in situ without evidence of disease. - adequately treated breast ductal carcinoma in situ without evidence of disease. - prostatic intraepithelial neoplasia without evidence of prostate cancer. - adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
  • 206 Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of Tarlatamab (Section 11.9).
  • 207 History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of first dose of Tarlatamab.
  • 208 Subject 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 Tarlatamab. NOTE: Simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor. Subjects requiring oral antibiotics who have been afebrile > 24 hours, have no leukocytosis and have no clinical signs of infection are eligible. Subjects who meet these criteria and who were previously on IV antimicrobials should have been off IV antimicrobials for > 48 hours.
  • 209 Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or peritoneal/pericardial catheter). NOTE: A pleural catheter or dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted.
  • Please refer to protocol for exclusion criteria 217 to 238.
  • 210 History of hypophysitis or pituitary dysfunction.
  • 211 Exclusion of hepatitis infection based on the following results and/or criteria: - Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B). - Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B. - Positive hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C
  • 212 Major surgery within 28 days of first dose Tarlatamab.
  • 214 Subject received prior therapy with Tarlatamab.
  • 215 Prior anti-cancer therapy within 28 days prior to first dose of Tarlatamab. Exceptions: - Subjects who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to grade <=1. - Prior palliative radiotherapy must have been completed at least 7 days before the first dose of Tarlatamab.
  • 216 Has a diagnosis of immunodeficiency (e.g. positive/non-negative test for human immunodeficiency virus) or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of Tarlatamab.
  • 202 Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
  • 203 Subjects who experienced recurrent pneumonitis (grade 2 or higher) or severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.

The study team makes the final eligibility decision.

Where it's taking place

  • United Kingdom
  • Canada
  • Korea, Republic of
  • Taiwan
  • Singapore
  • United States
  • Switzerland
  • Japan

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United Kingdom; Canada; Korea, Republic of; Taiwan; Singapore; United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.