Treatment for Advanced Non-small Cell Lung Cancer With Actionable Genomic Alterations After Targeted Treatment and Chemotherapy (An Expanded Lung-MAP Treatment Trial)

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

41 sites in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: A Randomized Phase II Study of Sacituzumab Govitecan Alone, Ivonescimab Alone, or Sacituzumab Govitecan and Ivonescimab in Participants With Previously-Treated Actionable Genomic Alteration Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)

Conditions

Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8

Being tested

Biospecimen Collection, Computed Tomography, Ivonescimab, Magnetic Resonance Imaging, Sacituzumab Govitecan

Medical subject headings

Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Biospecimen CollectionProcedure or surgery

  Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

  Undergo collection of blood samples

• Computed TomographyProcedure or surgery

  Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

  Undergo CT

• IvonescimabBiological

  Also called AK 112, AK-112, AK112, Anti-PD-1/Anti-VEGF Bispecific Antibody AK112

  Given IV

• Magnetic Resonance ImagingProcedure or surgery

  Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

  Undergo MRI

• Sacituzumab GovitecanBiological

  Also called hRS7-SN38 Antibody Drug Conjugate, IMMU 132, IMMU-132, IMMU132

  Given IV

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Progression-free survival (PFS) (Comparison between arms)

   Will compare between participants randomized to the combination of sacituzumab govitecan plus ivonescimab (SG-I) and sacituzumab govitecan (SG) alone. The comparison of PFS will be done using a 1-sided 10% level log-rank test stratified by randomization stratification factors. Binary proportions along with 90% confidence intervals will be estimated for response to be consistent with 1-sided 5% level testing. With 35 participants per arm, binary proportions can be estimated to within 11% with 90% confidence. The distribution PFS will be estimated using the method of Kaplan-Meier. Comparisons of event time distributions between arms will be summarized by hazard ratios and 80% confidence intervals (consistent with 1-sided 10% level testing) from a Cox Proportional hazards model including the stratification factors.

   Measured: From date of randomization to date of first documentation of progression, symptomatic deterioration, or death due to any cause, assessed up to 3 years

2. PFS (Comparison between arms)

   Will between participants randomized to SG-I and ivonescimab (I) alone. The comparison of PFS will be done using a 1-sided 10% level log-rank test stratified by randomization stratification factors. Binary proportions along with 90% confidence intervals will be estimated for response to be consistent with 1-sided 5% level testing. With 35 participants per arm, binary proportions can be estimated to within 11% with 90% confidence. The distribution PFS will be estimated using the method of Kaplan-Meier. Comparisons of event time distributions between arms will be summarized by hazard ratios and 80% confidence intervals (consistent with 1-sided 10% level testing) from a Cox Proportional hazards model including the stratification factors.

   Measured: From date of randomization to date of first documentation of progression, symptomatic deterioration, or death due to any cause, assessed up to 3 years

3. Response rate of SG against historical response rates (Single arm evaluation)

   Within each treatment arm, the objective is to evaluate if response rates show activity beyond standard of care, which generally would be single agent chemotherapy or docetaxel combined with ramucirumab. With 35 eligible and evaluable participants per arm, the evaluation has 90% exact power to rule out a 10% response rate using a 1-sided 5% level test (the exact level is 5.1% based on design assumptions), if the true response rate were at least 29%. The observation of at least 7 participants with a response (a 20% response rate) would be considered evidence to rule out a 10% response rate.

   Measured: Up to 3 years

4. Response rate of I against historical response rates (Single arm evaluation)

   Within each treatment arm, the objective is to evaluate if response rates show activity beyond standard of care, which generally would be single agent chemotherapy or docetaxel combined with ramucirumab. With 35 eligible and evaluable participants per arm, the evaluation has 90% exact power to rule out a 10% response rate using a 1-sided 5% level test (the exact level is 5.1% based on design assumptions), if the true response rate were at least 29%. The observation of at least 7 participants with a response (a 20% response rate) would be considered evidence to rule out a 10% response rate.

   Measured: Up to 3 years

5. Response rate of SG-I against historical response rates (Single arm evaluation)

   Within each treatment arm, the objective is to evaluate if response rates show activity beyond standard of care, which generally would be single agent chemotherapy or docetaxel combined with ramucirumab. With 35 eligible and evaluable participants per arm, the evaluation has 90% exact power to rule out a 10% response rate using a 1-sided 5% level test (the exact level is 5.1% based on design assumptions), if the true response rate were at least 29%. The observation of at least 7 participants with a response (a 20% response rate) would be considered evidence to rule out a 10% response rate.

   Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted6 Feb 2026
2. Study start22 Sep 2026
3. Primary completion30 Nov 2028 (estimated)
4. Study completionNov 2029 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Recurrent Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
• More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.