What side effects are associated with this type of intervention?

Common treatments for NSCLC, such as immune checkpoint inhibitors (e.g., pembrolizumab, nivolumab, atezolizumab) combined with chemotherapy, have known side effects including fatigue, nausea, decreased appetite, and rash. Severe adverse events can include pneumonitis, colitis, hepatitis, and endocrinopathies. Chemotherapy-related side effects often include myelosuppression, neuropathy, and gastrointestinal disturbances. MET inhibitors, like those studied in the APL-101 trial, may cause peripheral edema, nausea, vomiting, and fatigue. It is essential to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for Non-Small Cell Lung Cancer (NSCLC) with specific genetic alterations. For MET alterations, capmatinib (Tabrecta) is an FDA-approved MET inhibitor for NSCLC patients with MET exon 14 skipping mutations. Additionally, tepotinib (Tepmetko) is another MET inhibitor approved for the same indication. These drugs are similar to APL-101, which is being studied for its efficacy in treating NSCLC with MET exon 14 skipping mutations and other MET dysregulations. Other targeted therapies for NSCLC include osimertinib (Tagrisso) for EGFR mutations and crizotinib (Xalkori) for ALK rearrangements.

What other types of research exist?

Promising novel alternatives to APL-101 for NSCLC patients include: <ol> <li>AZD6244 (ARRY-142886) for patients with BRAF or RAS mutations.</li> <li></li> </ol> Apatinib in combination with pemetrexed-platinum chemotherapy for advanced non-squamous NSCLC. 3. Crizotinib for ALK-positive advanced non-squamous NSCLC. 4. Pembrolizumab, especially for patients with PD-L1 expression. 5. Osimertinib combined with apatinib for EGFR T790M-positive lung adenocarcinoma.

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Small Molecule Inhibitor

APL-101 for Lung Cancer (SPARTA Trial)

Phase 2

Recruiting

Led By Mark Awad, M.D.

Research Sponsored by Apollomics Inc.

Eligibility Criteria Checklist

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

Must have

ECOG performance status of 0-1. For subjects with primary CNS tumors, KPS score ≥70

Women of child-bearing potential must have a negative serum or Beta-hCG at screening or evidence of surgical sterility or evidence of post-menopausal status

Must not have

Subjects with active COVID-19 infection

Unable to swallow orally administered medication whole

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing APL-101, a new drug, on patients with specific genetic changes in their cancer. These patients often don't respond to typical treatments. The drug aims to block a protein that helps cancer cells grow and spread.

Who is the study for?

Adults with various cancers, including lung cancer with specific genetic changes (c-Met EXON 14 skip mutations), who have acceptable organ function and a life expectancy of at least 3 months. They must not be planning major surgery soon, can provide a tumor sample, and women should not be pregnant. People with uncontrolled infections or certain other health conditions are excluded.

What is being tested?

APL-101 Oral Capsules are being tested for their effectiveness as both a standalone treatment and an add-on therapy to EGFR inhibitors in patients with non-small cell lung cancer (NSCLC) and other solid tumors that show specific genetic alterations related to the MET gene.

What are the potential side effects?

While the trial information does not specify side effects, similar medications often cause digestive issues, fatigue, liver problems, skin reactions, and potential heart complications. Individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

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

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I can care for myself and perform daily activities, or if I have a brain tumor, my health status allows me to live a normal life.

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I am not pregnant, surgically sterile, or post-menopausal.

Exclusion Criteria

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

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I currently have an active COVID-19 infection.

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I cannot swallow pills whole.

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My cancer has a specific change in genes like EGFR, ALK, etc., except if I'm in Cohort C or C-2 for NSCLC.

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I have a digestive condition that affects how medicines work in my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 3 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

Objective response rate (ORR = CR + PR) per IRC committee (BIRC) based on RECIST v1.1 (or relevant criteria per tumor type)

Secondary study objectives

Antitumor activity by clinical benefit rate (CR + PR + SD ≥ 4 cycles) based on RECIST v1.1, RANO criteria for CNS tumors, or other relevant criteria per tumor type Median time to progression (TTP).

Median DOR per investigator assessment.

Median duration of response (DOR) per IRC.

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

9Treatment groups

Experimental Treatment

Group I: Primary CNS tumors with MET alterationsExperimental Treatment1 Intervention

Cohort E: APL-101 Oral Capsules

Group II: NSCLC MET amplification and EGFR wild-typeExperimental Treatment1 Intervention

Cohort C-1: APL-101 Oral Capsules

Group III: NSCLC Exon 14 Skip Treatment NaiveExperimental Treatment1 Intervention

Cohort A-1: APL-101 Oral Capsules

Group IV: NSCLC Exon 14 Skip Previously TreatedExperimental Treatment1 Intervention

Cohort A-2: APL-101 Oral Capsules

Group V: NSCLC Exon 14 MET Inhibitor ExperiencedExperimental Treatment1 Intervention

Cohort B: APL-101 Oral Capsules

Group VI: EGFR positive NSCLC MET amplification as an acquired resistanceExperimental Treatment1 Intervention

Cohort C-2: APL-101 Oral Capsules + Standard of Care EGFR Inhibitor

Group VII: Basket of tumor types wild-type MET with over-expression of HGF and METExperimental Treatment1 Intervention

Cohort F: APL-101 Oral Capsules

Group VIII: Basket of tumor types MET amplification except for primary CNS tumorsExperimental Treatment1 Intervention

Cohort C: APL-101 Oral Capsules

Group IX: Basket of solid tumor with MET gene fusions except for primary CNS tumorsExperimental Treatment1 Intervention

Cohort D: APL-101 Oral Capsules

0 / 6Eligibility 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

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies, immunotherapies, and chemotherapy. Targeted therapies, such as MET inhibitors like APL-101, work by blocking specific molecules involved in cancer cell growth and survival. For instance, MET inhibitors target the MET gene alterations, which can drive tumor growth in some NSCLC patients. Similarly, EGFR inhibitors target mutations in the EGFR gene, which are common in certain NSCLC subtypes. Immunotherapies, such as PD-1/PD-L1 inhibitors, enhance the immune system's ability to recognize and destroy cancer cells. These treatments are crucial for NSCLC patients as they offer more personalized and effective options, often with fewer side effects compared to traditional chemotherapy.

Improvement in lung cancer outcomes with targeted therapies: an update for family physicians.