Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New combo aims to outsmart Chemo-Resistant lung cancer

NCT ID NCT03896503

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 31, 2026 · Updated 4 times

Summary

This phase 2 trial tests whether adding berzosertib to standard chemotherapy (topotecan) helps people with relapsed small-cell lung cancer live longer without their cancer growing. About 104 participants will receive either the combo or topotecan alone. The goal is to see if berzosertib can block cancer cells from repairing DNA damage caused by chemo, making the treatment more effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
berzosertib (M6620, VX-970) combined with topotecan hydrochloride
What this could lead to
If successful, this combination could offer a new treatment option that delays cancer progression in patients with relapsed small-cell lung cancer.
What could go wrong
This is a mid-stage trial with only 104 participants, so results may not be definitive. Adding berzosertib may increase side effects without improving outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

104 people

The number who actually took part.

Started

Dec 2019

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients enrolled to the primary cohort must have limited- or extensive-disease SCLC at diagnosis, with relapse at study entry with measurable disease at random assignment per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Both platinum-sensitive and platinum-resistant patients will be included * Patients with extrapulmonary small cell cancers (cancers with small cell morphology and arising outside the lung, such as small cell prostate, bladder, etc.) will be eligible for the exploratory cohort * Patients must be \>= 18 years of age because no dosing or adverse event data are currently available on the use of M6620 in combination with topotecan in patients \<18 years of age * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%) * Hemoglobin \>= 9.0 g/dL - patients may receive transfusion to meet the hemoglobin (Hb) eligibility * Absolute neutrophil count (ANC) \>= 1,500/mcL * Platelets \>= 100,000/mcL * Total bilirubin =\< 2 mg/dL * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x institutional upper limit of normal (ULN) * Creatinine =\< institutional ULN OR * Glomerular filtration rate (GFR) \>= 60 mL/min/1.73 m\^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m\^2 * Human immunodeficiency virus (HIV)-positive subjects on combination antiretroviral therapy are eligible as long as they are on effective anti-retroviral therapy with undetectable viral load within 6 months and there is no drug-drug interaction with M6220 * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * The effects of M6620 on the developing human fetus are unknown. For this reason and because DNA-damage response (DDR) inhibitors as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after completion of M6620 administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 months after completion of M6620 administration * Patients with treated brain metastases are eligible if they are symptomatically stable while off steroid therapy for a minimum of 21 days * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients with symptomatic brain metastasis are not eligible due to their extremely poor prognosis and since it is unclear whether the investigational agent penetrates the blood-brain barrier. However, subjects who have had treatment for their brain metastasis and are symptomatically stable while off steroid therapy for a minimum of 21 days may be enrolled * Patients who have received prior topotecan therapy * Patients who have had chemotherapy or radiotherapy within 3 weeks prior to enrollment. * Note: Patients who have had palliative radiotherapy may be included as long as they have recovered from any radiotherapy related adverse events (allow at least a week between radiotherapy completion and study treatment) * Patients who have not recovered from adverse events due to prior anti-cancer therapy except hair loss and peripheral neuropathy (i.e., have residual toxicities \> grade 1) * Patients who are receiving any other investigational agents * History of allergic reactions attributed to compounds of similar chemical or biologic composition to M6620 or topotecan used in study * M6620 is primarily metabolized by cytochrome P450 3A4 (CYP3A4); therefore, concomitant administration with strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, nelfinavir and saquinavir) or inducers of CYP3A4 (e.g., rifampin, phenytoin, carbamazepine, phenobarbital, St. John's wort) should be avoided. Patients requiring any medications or substances that are strong inhibitors or inducers of CYP3A during the course of the study are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference for a list of drugs to avoid or of which to minimize use. The Patient Drug Interactions Handout and Wallet Card should be provided to patients. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product * Patients with uncontrolled intercurrent illness * Pregnant women are excluded from this study because M6620 as a DDR inhibitor may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with M6620, breastfeeding should be discontinued if the mother is treated with M6620. These potential risks may also apply to topotecan used in this study * Patients with high grade neuroendocrine cancers, but with no small cell morphology will not be eligible * Patients with psychiatric illness/social situations that would limit compliance with study requirements * Patients with Li-Fraumeni syndrome will not be eligible

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Extensive stage lung small cell carcinoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

small cell carcinoma small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Extensive stage lung small cell carcinoma Extrapulmonary small cell neuroendocrine carcinoma Limited stage lung small cell carcinoma Platinum-resistant lung small cell carcinoma Platinum-sensitive lung small cell carcinoma Recurrent lung small cell carcinoma

Contacts and locations

Locations

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756, United States

  • HaysMed

    Hays, Kansas, 67601, United States

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016, United States

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044, United States

  • Los Angeles General Medical Center

    Los Angeles, California, 90033, United States

  • Mercy Hospital Pittsburg

    Pittsburg, Kansas, 66762, United States

  • NCI - Center for Cancer Research

    Bethesda, Maryland, 20892, United States

  • Parkland Memorial Hospital

    Dallas, Texas, 75235, United States

  • Salina Regional Health Center

    Salina, Kansas, 67401, United States

  • The University of Kansas Cancer Center - Olathe

    Olathe, Kansas, 66061, United States

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045, United States

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • USC Norris Oncology/Hematology-Newport Beach

    Newport Beach, California, 92663, United States

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390, United States

  • University Health Truman Medical Center

    Kansas City, Missouri, 64108, United States

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817, United States

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160, United States

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064, United States

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154, United States

  • University of Kansas Cancer Center at North Kansas City Hospital

    North Kansas City, Missouri, 64116, United States

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, 66210, United States

  • University of Kansas Clinical Research Center

    Fairway, Kansas, 66205, United States

  • University of Kansas Health System Saint Francis Campus

    Topeka, Kansas, 66606, United States

  • University of Kansas Hospital-Indian Creek Campus

    Overland Park, Kansas, 66211, United States

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205, United States

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536, United States

  • Wake Forest Baptist Health - Hematology Oncology - Statesville

    Statesville, North Carolina, 28677, United States

  • Wake Forest Baptist Health - Wilkes Medical Center

    Wilkesboro, North Carolina, 28659, United States

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157, United States

  • Wake Forest University at Clemmons

    Clemmons, North Carolina, 27012, United States

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.