What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) similar to ceralasertib and durvalumab include ATR kinase inhibitors and anti-PD-L1 monoclonal antibodies. ATR kinase inhibitors can cause side effects such as fatigue, nausea, anemia, and thrombocytopenia. Anti-PD-L1 monoclonal antibodies are associated with immune-related adverse events, including pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Combination therapies may increase the risk of these side effects.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of NSCLC. Pembrolizumab (Keytruda) and nivolumab (Opdivo) are anti-PD-1 monoclonal antibodies approved for various stages of NSCLC, often in combination with chemotherapy. Atezolizumab (Tecentriq), an anti-PD-L1 antibody, has also been approved for NSCLC, both as monotherapy and in combination with chemotherapy. Durvalumab (Imfinzi), another anti-PD-L1 antibody, is approved for unresectable stage III NSCLC following chemoradiation therapy. These approvals highlight the growing role of immunotherapy in NSCLC treatment, similar to the combination of ceralasertib (an ATR kinase inhibitor) and durvalumab being studied in the referenced trial.

What other types of research exist?

Promising novel alternatives for NSCLC treatment include: 1) Larotrectinib for patients with NTRK1 fusion variants, which has shown significant reduction in lesion sizes. 2) Ceritinib, an ALK inhibitor recently approved by the FDA for locally advanced and metastatic NSCLC. 3) Alectinib, ASP3026, and X396, which are in active clinical development and have demonstrated safety, selectivity, and potency. 4) Dual inhibitors targeting ALK and other pathways, such as AP26113 (ALK and EGFRm), TSR011 (ALK and TRK), and RXDX-101 (ALK and ROS1).

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PARP Inhibitor

Ceralasertib + Durvalumab for Lung Cancer (LATIFY Trial)

Phase 3

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Eligible for second- or third-line therapy and must have received an anti-PD-(L)1 therapy and a platinum doublet containing therapy for locally advanced or metastatic NSCLC either separately or in combination

Documented radiological PD whilst on or after receiving the most recent treatment regimen

Must not have

Participant with mixed SCLC and NSCLC histology

Persistent toxicities (CTCAE Grade > 2) caused by previous anticancer therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests a new combination of drugs (ceralasertib and durvalumab) against a standard treatment (docetaxel) in patients with advanced lung cancer who didn't respond to previous treatments. The new combination aims to weaken cancer cells and boost the immune system, while the standard treatment directly kills the cancer cells.

Who is the study for?

This trial is for adults with advanced NSCLC who have already tried anti-PD-(L)1 and platinum-based chemotherapy without success. They should not be pregnant, must have a good performance status (able to carry out daily activities), adequate organ function, and no severe weight loss due to cancer. People with certain other cancers or those who've had serious side effects from previous immunotherapies can't join.

What is being tested?

The study compares the effectiveness of Ceralasertib combined with Durvalumab against the standard treatment Docetaxel in patients whose NSCLC has worsened despite prior therapies. It aims to see if this new combination can improve outcomes for these patients.

What are the potential side effects?

Possible side effects include immune system reactions that could affect organs, infusion-related responses, fatigue, digestive issues like nausea or diarrhea, blood cell count changes increasing infection risk, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I've had treatments for advanced lung cancer including anti-PD-(L)1 and platinum-based therapy.

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My cancer has worsened despite my most recent treatment.

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My lung cancer is advanced or has spread, as confirmed by tests.

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I weigh more than 30 kg and do not have severe weight loss due to cancer.

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My cancer is not caused by changes in the EGFR or ALK genes.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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My lung cancer is a mix of small cell and non-small cell types.

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I have lasting side effects from cancer treatment that are moderate to severe.

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I had cancer before, but it was treated over 5 years ago and hasn't come back.

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I have had more than one platinum-based chemotherapy for my cancer.

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I stopped my previous anti-PD(L)1 therapy due to severe side effects.

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I have been treated with more than one anti-PD-(L)1 therapy.

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I have not had severe immune side effects from previous anti-PD(L)1 therapy.

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I have previously been treated with an ATR inhibitor.

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I have or had an autoimmune or inflammatory disorder.

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All side effects from my previous immunotherapy have gone away.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Overall Survival (OS)

Secondary study objectives

Disease Control Rate (DCR)

Duration of Response (DoR)

Number of participants with Adverse Evens (AEs)

+8 more

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group A: Ceralasertib plus durvalumab combination therapyExperimental Treatment2 Interventions

Participants will be administered ceralasertib orally followed by durvalumab administered intravenously.

Group II: Group B: Docetaxel monotherapyActive Control1 Intervention

Participants will be administered docetaxel (standard of care) administered intravenously.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ceralasertib

Not yet FDA approved

Durvalumab

FDA approved

0 / 16Eligibility 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 and immunotherapies. Ceralasertib, an ATR kinase inhibitor, works by interfering with the DNA damage response in cancer cells, leading to cell death, particularly in cells already stressed by other treatments like chemotherapy. Durvalumab, an anti-PD-L1 monoclonal antibody, enhances the immune system's ability to recognize and destroy cancer cells by blocking the PD-L1 protein, which tumors use to evade immune detection. These mechanisms are crucial for NSCLC patients as they offer targeted approaches to disrupt cancer cell survival and enhance immune response, potentially leading to better outcomes and prolonged survival.

CCTG BR34: A Randomized Phase 2 Trial of Durvalumab and Tremelimumab With or Without Platinum-Based Chemotherapy in Patients With Metastatic NSCLC.Rationale and design of a phase II trial of durvalumab treatment in patients with NSCLC ineligible for stage III chemoradiotherapy following radiation monotherapy (SPIRAL-RT study).MEDI 4736 (durvalumab) in non-small cell lung cancer.