Health TrialsbyHealthPanel

Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)

ConditionSmall Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-99
SponsorAmgen

About this trial

The primary objective of this trial is to evaluate the safety and tolerability of tarlatamab in combination with ZL-1310 with or without durvalumab and to determine the maximum tolerated combination dose (MTCD) and/or recommended phase 2 dose (RP2D) of ZL-1310 in combination with tarlatamab.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.

For Part 1, participants must have SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy.

For Parts 1 and 2, participants must have progressed or recurred following at least 1 line of platinum-based therapy. No prior tarlatamab is allowed in Cohort 2-1.

For Part 3, participants must have extensive-stage SCLC (ES-SCLC) with no prior systemic treatment other than 1 cycle of platinum-based chemotherapy.

Disqualifiers

Symptomatic CNS metastases. Participants with treated brain metastases are eligible provided they meet the criteria specified in the protocol.

History of interstitial lung disease (ILD)/pneumonitis.

Received thoracic radiation therapy within 90 days prior to first dose of trial intervention.

Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy.

Trial design

Design model

Sequential

Treatments tested in this trial

  • ZL-1310

    Drug

    ZL-1310 will be administered as an IV infusion.

  • Tarlatamab

    Drug

    Tarlatamab will be administered as an IV infusion.

  • Durvalumab

    Drug

    Durvalumab will be administered as an IV infusion.

Treatment groups

160 Participants
are divided into 3 treatment groups
Group A: Dose Exploration (Part 1)Experimental treatment 2 interventions
Group B: Dose Expansion (Part 2)Experimental treatment 2 interventions
Group C: Triplet Combination (Part 3)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

Time frame
Up to 3.5 years
2

Parts 1 and 3: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)

Time frame
Up to Day 21

Secondary outcomes

1

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Time frame
Up to 3.5 years
2

Duration of Response (DOR) per RECIST v1.1

Time frame
Up to 3.5 years
3

Time to Response (TTR) per RECIST v1.1

Time frame
Up to 3.5 years
4

Disease Control Rate (DCR) per RECIST v1.1

Time frame
Up to 3.5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amgen

Lead sponsor

Source ClinicalTrials.gov
Apply now