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Monoclonal Antibodies
Tarlatamab for Small Cell Lung Cancer (DeLLphi-301 Trial)
Phase 2
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed relapsed/refractory SCLC
Participants who progressed or recurred following 1 platinum-based regimen and at least 1 other prior line of therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to a maximum of 24 months
Awards & highlights
DeLLphi-301 Trial Summary
This trial is testing a new cancer drug to see if it is safe and effective. The drug will be given to two different groups of people to see what dose is best. The study will also look at how well the drug works against cancer.
Who is the study for?
This trial is for adults over 18 with relapsed/refractory Small Cell Lung Cancer (SCLC) who have tried at least one platinum-based therapy and another treatment. They must have a life expectancy of at least 12 weeks, measurable cancer lesions, and be in fairly good health (ECOG status of 0 or 1). Participants with treated brain metastases may join if they meet certain criteria. Pregnant women, those planning to become pregnant, or breastfeeding are excluded, as well as anyone unwilling to use contraception.Check my eligibility
What is being tested?
The study tests two dose levels of Tarlatamab for safety and effectiveness against SCLC tumors. It's divided into parts: the first evaluates safety/effectiveness per RECIST 1.1 standards; the second assesses tumor response rate by independent review; the third looks at safety regarding reduced monitoring after initial doses.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones from treatments like Tarlatamab can include immune-related reactions such as inflammation in organs, fatigue, infusion reactions similar to allergic responses during drug administration, digestive issues like nausea or diarrhea, blood disorders affecting cell counts leading to increased infection risk.
DeLLphi-301 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My small cell lung cancer has come back or didn't respond to treatment.
Select...
My cancer returned or worsened after 1 platinum-based treatment and another therapy.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
DeLLphi-301 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to a maximum of 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to a maximum of 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1 Only: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator
Part 1 Only: Serum Concentrations of Tarlatamab
Part 1 and Part 2 Only: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR)
+1 moreSecondary outcome measures
Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR)
Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator
Duration of Disease Control (DC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR)
+10 moreDeLLphi-301 Trial Design
4Treatment groups
Experimental Treatment
Group I: Part 3: Modified Monitoring SubstudyExperimental Treatment1 Intervention
Participants will receive the selected target dose of Tarlatamab based on findings in Part 1 with reduced Cycle 1 monitoring requirements.
Group II: Part 2: Dose ExpansionExperimental Treatment1 Intervention
Participants will receive the selected target dose of Tarlatamab based on findings in Part 1.
Group III: Part 1: Tarlatamab Low DoseExperimental Treatment1 Intervention
Participants will receive the low dose of Tarlatamab.
Group IV: Part 1: Tarlatamab High DoseExperimental Treatment1 Intervention
Participants will receive the high dose of Tarlatamab.
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Who is running the clinical trial?
AmgenLead Sponsor
1,370 Previous Clinical Trials
1,377,466 Total Patients Enrolled
MDStudy DirectorAmgen
913 Previous Clinical Trials
923,909 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot find someone to stay with me for 72 hours after my first two tarlatamab treatments.I haven't had any live vaccines in the last 28 days and won't during the study, except for a Monkeypox vaccine after cycle 1.I can attend all required study visits and follow the study procedures.I had COVID-19 but have been symptom-free for the last 14 days.I can stay near the study site for 48 hours after my first two tarlatamab treatments.My small cell lung cancer has come back or didn't respond to treatment.I am a woman able to have children and agree to use birth control as required.I am not pregnant, as confirmed by a sensitive test.I haven't had a stroke or mini-stroke in the last year.I am not planning to become pregnant during the study or within 72 days after the last dose.I have brain metastases or leptomeningeal disease that hasn't been treated or is causing symptoms.I have a lung condition not caused by an infection.I had severe reactions to previous immune therapy.I have not had any other cancer in the last 2 years, with some exceptions.I can stay within an hour of a hospital for 3 days after my first two tarlatamab treatments.I agree to use contraception or abstain from sex if my partner is pregnant while I'm on tarlatamab and for 132 days after.You will be excluded if you have hepatitis based on specific test results or criteria in the study plan.I have not had major surgery in the last 4 weeks.I have not taken steroids or immunosuppressants in the last 7 days.I have not received any live vaccines recently.I am a man who will use birth control or abstain from sex while on treatment and for 132 days after.My cancer returned or worsened after 1 platinum-based treatment and another therapy.I haven't had signs of a serious infection in the last week.I have not had certain treatments before or alongside my current therapy.I have had issues with my pituitary gland.My condition is related to my disease.I am not breastfeeding nor plan to while on the study and for 72 days after the last dose.I haven't had a heart attack or severe heart failure in the last year.I can receive live vaccines 42 days after my last tarlatamab dose.I have previously been treated with tarlatamab.I haven't had cancer treatment in the last 28 days.I am 18 years or older and can legally consent.I agree not to donate sperm during and for 132 days after my last dose of tarlatamab.I am willing to provide previous tumor samples or undergo a biopsy.My cancer can be measured by scans and was checked within the last 21 days.I am fully active or restricted in physically strenuous activity but can do light work.I have had treatment for brain metastases and meet specific criteria.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1: Tarlatamab Low Dose
- Group 2: Part 1: Tarlatamab High Dose
- Group 3: Part 2: Dose Expansion
- Group 4: Part 3: Modified Monitoring Substudy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many study participants are currently enrolled?
"That is correct, the trial detailed on clinicaltrials.gov is currently seeking patients for enrollment. This particular study was first posted on December 1st, 2021 and edited most recently on October 26th, 2022. In total, they are aiming to enroll 160 people from 12 different locations."
Answered by AI
Has Tarlatamab received FDA approval for therapeutic use?
"Tarlatamab's safety is estimated to be a 2. This is due to it being in Phase 2 of clinical trials, which means that while there is data supporting its safety, there is none yet confirming its efficacy."
Answered by AI
Are there any current vacancies for people who wish to participate in this research?
"That is correct. According to the information available on clinicaltrials.gov, this study requires 160 participants and is being conducted at 12 locations. The trial was created on December 1st, 2021 and updated October 26th, 2022."
Answered by AI
In how many treatment centers is this study being conducted?
"The principle hospitals conducting this research are Dana Farber - Harvard Cancer Center in Boston, Massachusetts, Winship Cancer Institute in Atlanta, Georgia, and Dartmouth Hitchcock Medical Center in Hanover, New hampshire. There are also 12 other clinical trial sites."
Answered by AI
Who else is applying?
What state do they live in?
South Carolina
What portion of applicants met pre-screening criteria?
Met criteria
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