What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC), particularly those involving immune checkpoint inhibitors and chemotherapy, have several known side effects. Immune checkpoint inhibitors like pembrolizumab and atezolizumab can cause fatigue, rash, diarrhea, and immune-related adverse events such as pneumonitis, colitis, hepatitis, and endocrinopathies. Chemotherapy agents like carboplatin, paclitaxel, and pemetrexed often lead to nausea, vomiting, hair loss, myelosuppression (anemia, neutropenia, thrombocytopenia), and neuropathy. Combining these treatments can increase the risk of overlapping toxicities, requiring careful monitoring and supportive care.

What prior FDA approvals exist?

Several immunotherapy drugs have received FDA approval for the treatment of Non-Small Cell Lung Cancer (NSCLC). Pembrolizumab, an anti-PD-1 therapy, has been approved for use in combination with chemotherapy for metastatic NSCLC, as demonstrated in the KEYNOTE-189 trial. Atezolizumab, an anti-PD-L1 therapy, has also been approved in combination with bevacizumab and chemotherapy for advanced nonsquamous NSCLC, as shown in the IMpower150 trial. These approvals highlight the effectiveness of combining immunotherapy with traditional chemotherapy in treating NSCLC.

What other types of research exist?

Promising novel alternatives for NSCLC patients include: 1) Atezolizumab plus Carboplatin plus Pemetrexed plus Bevacizumab (ACBPem) as evaluated in the BTCRC-LUN 17-139 trial, 2) Sintilimab plus Pemetrexed and Platinum, as shown in a phase 3 study, and 3) Furmonertinib for EGFR mutation-positive NSCLC, as demonstrated in the FURLONG study.

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ABBV-514 + Budigalimab for Lung & Head and Neck Cancers

Q: What is the mechanism of action of this treatment?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies and immunotherapies. Targeted therapies, such as tyrosine kinase inhibitors (TKIs), work by blocking specific molecules and pathways that are essential for cancer cell growth and survival. Immunotherapies, like PD-1/PD-L1 inhibitors, enhance the body's immune response against cancer cells by preventing the cancer from evading immune detection. These mechanisms are important for NSCLC patients as they allow for more personalized and effective treatment options, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.

Phase 1

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Relapsed Non-Small Cell Lung Cancer (NSCLC) Head and Neck Squamous Cell Carcinoma (HNSCC) dose-expansion cohorts only: Must have histologically or cytologically confirmed advanced or metastatic NSCLC or HNSCC that is not suitable for surgical resection and/or radiation therapy and has been treated with platinum-based chemotherapy and a programmed cell death (PD)-1 or PD ligand 1 (PD-L1) targeting agent (separately or in combination therapy). Must have failed (or refused) treatment with available therapies known to be active for treatment of their disease. Participants enrolled in dose escalation must have disease that is evaluable or measurable per Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1). Participants enrolled in dose expansion must have measurable disease per RECIST, version 1.1. Eastern Cooperative Oncology Group (ECOG) performance status of <= 1. Laboratory values meeting the criteria outlined in the protocol.

Dose-escalation cohorts only: Must have an advanced solid tumor who are considered refractory to or intolerant of all existing therapies known to provide a clinical benefit for their condition.

Must not have

Relapsed Non-Small Cell Lung Cancer (NSCLC) Head and Neck Squamous Cell Carcinoma (HNSCC) dose-expansion cohorts only: Non-Small Cell Lung Cancer (NSCLC) participants with known EGFR mutations or ALK gene rearrangements are ineligible.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two experimental drugs, ABBV-514 and Budigalimab, on adults with specific types of cancer. The goal is to find out if these drugs can help treat lung and head/neck cancers by monitoring their effects and side effects.

Who is the study for?

Adults with advanced or metastatic NSCLC or HNSCC that have relapsed after platinum-based chemotherapy and PD-1/PD-L1 therapy can join. They must have measurable disease, meet certain lab criteria, and be in good physical condition (ECOG ≤ 1). Those with specific genetic mutations (EGFR, ALK) in NSCLC are excluded.

What is being tested?

The trial is testing ABBV-514 alone or combined with Budigalimab on patients with NSCLC and HNSCC. It aims to find the highest dose patients can tolerate without severe side effects. Participants will receive IV infusions of these drugs for up to two years at hospitals or clinics worldwide.

What are the potential side effects?

Potential side effects include reactions related to the infusion process, changes in blood tests indicating organ function issues, fatigue, and other symptoms as a result of how the drugs affect cancer cells and healthy tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My advanced cancer has not responded to or I cannot tolerate any known treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My lung cancer has returned but does not have EGFR mutations or ALK rearrangements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Antidrug Antibody (ADA)

Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-514

Maximum Observed Serum Concentration (Cmax) of ABBV-514

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part 2 Dose Expansion: ABBV-514 + BudigalimabExperimental Treatment2 Interventions

Participants will receive ABBV-514 at recommended dose determined in Dose Escalation portion in combination with budigalimab.

Group II: Part 2 Dose Expansion: ABBV-514Experimental Treatment1 Intervention

Participants will receive ABBV-514 at recommended dose determined in Dose Escalation portion.

Group III: Part 1 Dose Escalation: ABBV-514 + BudigalimabExperimental Treatment2 Interventions

Participants will receive ABBV-514 in combination with budigalimab.

Group IV: Part 1 Dose Escalation: ABBV-514Experimental Treatment1 Intervention

Participants will receive ABBV-514.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Budigalimab

2021

Completed Phase 1

~170

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies and immunotherapies. Targeted therapies, such as tyrosine kinase inhibitors (TKIs), work by blocking specific molecules and pathways that are essential for cancer cell growth and survival. Immunotherapies, like PD-1/PD-L1 inhibitors, enhance the body's immune response against cancer cells by preventing the cancer from evading immune detection. These mechanisms are important for NSCLC patients as they allow for more personalized and effective treatment options, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.

Emerging therapeutic agents for lung cancer.Clinical trials of tyrosine kinase inhibitors for lung cancer in China: a review.A tabulated summary of targeted and biologic therapies for non-small-cell lung cancer.