A Phase 2 interventional study of MM-121 and Docetaxel in Non-Small Cell Lung Cancer, NSCLC and Adenocarcinoma, sponsored by Elevation Oncology. Terminated at 35 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-12.
Sponsored by Elevation Oncology · Phase 2, Interventional, and Treatment
The purpose of this study is to determine whether the combination of MM-121 plus docetaxel is more effective than docetaxel alone in regards to PFS in patients with heregulin-positive NSCLC.
This study is a randomized, open-label, international, multi-center, phase 2 study in patients with Heregulin-positive NSCLC histologically classified as adenocarcinoma that have progressed following no more than two systemic therapies for locally advanced or metastatic disease, one of which must have been a platinum containing regimen. All patients will initially be screened for heregulin status. Eligible patients will be randomized to receive MM-121 in combination with docetaxel versus docetaxel alone.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 153 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Elevation Oncology is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
MM-121 in combination with Docetaxel
Drug: MM-121 · Drug: Docetaxel
Docetaxel alone
Drug: Docetaxel
Investigational, fully human antibody targeting and inhibiting ErbB3
Also known as: seribantumab
approved chemotherapy treatment for NSCLC
Also known as: Taxotere
Progression Free Survival
Progression Free Survival is defined as the time from randomization to the first documented radiographical progression of disease using RECIST v.1.1, or death from any cause, whichever came first based on investigator assessment. Patients that do not experience progression or death at the time of analysis were to be progression censored at the date of last valid tumor assessment. Progression-free survival time distribution and median survival for each treatment group were analyzed using the Kaplan-Meier method. Tumor response was evaluated by the local radiologist according to RECIST version 1.1 to establish disease progression by CT or MRI.
Time frame: Randomization until progression of disease or death due to any cause within 3 years,11 months (the study terminated prematurely)
Overall Survival
Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause
Time frame: From date of randomization until the date of death from any cause assessed upto 3 years,11 months (the study terminated prematurely)
Objective Response Rate
Objective Response Rate (ORR) is defined as the proportion of patients a best overall response characterised as either a Complete Response (CR) or Partial Response (PR), as defined according to RECIST v1.1 guidelines, relative to the total number of evaluable patients. Complete Response (CR) is defined as disappearance of all lesions and pathologic lymph nodes. Partial Response (PR) is defined as \>=30% decrease in the sum of the longest diameter of target lesions
Time frame: Randomization through end of study up to 3 years, 11 months (the study terminated prematurely)
Time to Progression
Time to Progression (TTP) is defined as the time from the date of randomization to the date of objective tumor progression. In the actual analysis, duration of response (DOR) was analysed.
Time frame: Randomization to date of objective tumor progression up to 3 years, 11 months (the study terminated prematurely)
Number of Participants With Treatment-emergent Adverse Events Reported With the Combination of MM-121 With Docetaxel Versus Docetaxel Alone
Treatment-emergent adverse events (TEAEs) are defined as any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration
Time frame: TEAEs were collected through the study completion (02 Jan 2019), up to 3 years, 11 months
Pharmacokinetic (PK) Parameters of MM-121 in Combination With Docetaxel and Docetaxel When Given in Combination With MM-121.
Pharmacokinetic (PK) profile of MM-121 when given in combination with docetaxel, and of docetaxel when given in combination with MM-121. The maximum observed concentration (Cmax) were to be presented and calculated using non-compartmental analysis. Serum levels of MM-121 were to be measured at a central lab using an enzyme-linked immunosorbent assay.
Time frame: The study terminated prematurely after 3 years, 11 months (02 Jan 2019). PK evaluation were to be performed on samples obtained at Week 1 pre-dose and post-dose and at pre-dose at Cycle 2 and beyond to assess pre-treatment through concentrations of MM-121
Percentage of Participants With Treatment-emergent Adverse Events Reported With the Combination of MM-121 With Docetaxel Versus Docetaxel Alone
Treatment-emergent adverse events (TEAEs) are defined as any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration
Time frame: TEAEs were collected through the study completion (02 Jan 2019), up to 3 years, 11 months
87 multi-national sites
| Milestone | Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone |
|---|---|---|
| Started | 103 | 49 |
| Completed | 3 | 2 |
| Not completed | 100 | 47 |
| Withdrew: Progressive disease | 2 | 0 |
| Withdrew: Withdrawal by subject | 3 | 5 |
| Withdrew: Physician decision | 2 | 0 |
| Withdrew: Sponsor decision | 28 | 12 |
| Withdrew: Death | 60 | 23 |
| Withdrew: Other | 5 | 4 |
| Withdrew: Lost to follow-up | 0 | 3 |
Progression Free Survival is defined as the time from randomization to the first documented radiographical progression of disease using RECIST v.1.1, or death from any cause, whichever came first based on investigator assessment. Patients that do not experience progression or death at the time of analysis were to be progression censored at the date of last valid tumor assessment. Progression-free survival time distribution and median survival for each treatment group were analyzed using the Kaplan-Meier method. Tumor response was evaluated by the local radiologist according to RECIST version 1.1 to establish disease progression by CT or MRI.
| months | Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone |
|---|---|---|
| Progression Free Survival | 3.4 (1.9 to 5.7) | 4.1 (2.7 to 6.3) |
Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause
| months | Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone |
|---|---|---|
| Overall Survival | 7.7 (3.6 to 10.4) | 8.4 (5.8 to 14.7) |
Objective Response Rate (ORR) is defined as the proportion of patients a best overall response characterised as either a Complete Response (CR) or Partial Response (PR), as defined according to RECIST v1.1 guidelines, relative to the total number of evaluable patients. Complete Response (CR) is defined as disappearance of all lesions and pathologic lymph nodes. Partial Response (PR) is defined as \>=30% decrease in the sum of the longest diameter of target lesions
| Participants | Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone |
|---|---|---|
| Objective Response | 14 | 2 |
| Partial Response (PR) | 14 | 2 |
| Stable Disease (SD) | 39 | 26 |
| Progressive Disease | 12 | 5 |
| Not Evaluable | 1 | 1 |
| No Evaluation | 5 | 4 |
Time to Progression (TTP) is defined as the time from the date of randomization to the date of objective tumor progression. In the actual analysis, duration of response (DOR) was analysed.
| months | Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone |
|---|---|---|
| Time to Progression | 3.0 (2.8 to 5.2) | NA (NA to NA) |
Treatment-emergent adverse events (TEAEs) are defined as any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration
| participants | Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone |
|---|---|---|
| Patients with any TEAE-Related | 99 | 45 |
| Patients with any TEAE-Serious Adverse event | 40 | 15 |
| Patients with any NCI-CTCAE Grade 3 or Higher | 76 | 31 |
Pharmacokinetic (PK) profile of MM-121 when given in combination with docetaxel, and of docetaxel when given in combination with MM-121. The maximum observed concentration (Cmax) were to be presented and calculated using non-compartmental analysis. Serum levels of MM-121 were to be measured at a central lab using an enzyme-linked immunosorbent assay.
No measurements were reported for this outcome.
Treatment-emergent adverse events (TEAEs) are defined as any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration
| percentage of participants | Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone |
|---|---|---|
| TEAE-Related | 96.1 | 91.8 |
| TEAE-Serious Adverse event | 38.8 | 30.6 |
| NCI-CTCAE Grade 3 or Higher | 73.8 | 63.3 |
Collected over From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A (Experimental): MM-121 in Combination With Docetaxel | 64/103 (62.1%) | 40/103 (38.8%) | 103/103 (100%) |
| Arm B (Comparator): Docetaxel Alone | 25/49 (51%) | 15/49 (30.6%) | 47/49 (95.9%) |
| Event | Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone |
|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 7/103 | 4/49 |
| PneumoniaInfections and infestations | 8/103 | 1/49 |
| DiarrhoeaGastrointestinal disorders | 6/103 | 0/49 |
| SepsisInfections and infestations | 1/103 | 2/49 |
| ColitisGastrointestinal disorders | 3/103 | 0/49 |
| PyrexiaGeneral disorders | 3/103 | 0/49 |
| AnaemiaBlood and lymphatic system disorders | 2/103 | 1/49 |
| NeutropeniaBlood and lymphatic system disorders | 1/103 | 1/49 |
| Atrial fibrillationCardiac disorders | 0/103 | 1/49 |
| Neutropenic colitisGastrointestinal disorders | 0/103 | 1/49 |
| Event | Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 52/103 | 11/49 |
| FatigueGeneral disorders | 45/103 | 16/49 |
| Decreased appetiteMetabolism and nutrition disorders | 34/103 | 8/49 |
| NauseaGastrointestinal disorders | 30/103 | 14/49 |
| AnaemiaBlood and lymphatic system disorders | 29/103 | 11/49 |
| NeutropeniaBlood and lymphatic system disorders | 29/103 | 11/49 |
| AstheniaGeneral disorders | 28/103 | 11/49 |
| AlopeciaSkin and subcutaneous tissue disorders | 23/103 | 13/49 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 20/103 | 9/49 |
| StomatitisGastrointestinal disorders | 19/103 | 2/49 |
Patients that have signed informed consent, identified as HRG positive based on centralized tissue analysis,\& have successfully completed study entry criteria (Safety Population- patients receiving at least one dose of study medication. All safety analyses were performed on either the Modified Intent-to-Treat (mITT) Population or this population).
| Age, Categorical(Participants) | Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 58 | 31 | 89 |
| >=65 years | 45 | 18 | 63 |
| Age, Continuous(years) | Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone | Total |
|---|---|---|---|
| Mean | 62.6 ± 10.07 | 62.8 ± 7.28 | 62.8 ± 8.68 |
| Sex: Female, Male(Participants) | Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone | Total |
|---|---|---|---|
| Female | 32 | 19 | 51 |
| Male | 71 | 30 | 101 |
| Ethnicity (NIH/OMB)(Participants) | Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 4 | 10 |
| Not Hispanic or Latino | 90 | 41 | 131 |
| Unknown or Not Reported | 7 | 4 | 11 |
| Race (NIH/OMB)(Participants) | Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 10 | 2 | 12 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 4 |
| White | 83 | 38 | 121 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 8 | 7 | 15 |
| Region of Enrollment(participants) | Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone | Total |
|---|---|---|---|
| Australia | 9 | 3 | 12 |
| Canada | 2 | 6 | 8 |
| France | 11 | 6 | 17 |
| Germany | 7 | 4 | 11 |
| Hungary | 1 | 1 | 2 |
| Poland | 2 | 2 | 4 |
| South Korea | 0 | 1 | 1 |
| Spain | 28 | 10 | 38 |
| Taiwan | 2 | 1 | 3 |
| Thailand | 3 | 0 | 3 |
| United States | 38 | 15 | 54 |
| Metastatic burden (TNM Stage at Initial Diagnosis)(Participants) | Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone | Total |
|---|---|---|---|
| Stage IIA | 5 | 3 | 8 |
| Stage IIB | 1 | 1 | 2 |
| Stage IIIA | 7 | 4 | 11 |
| Stage IIIB | 13 | 8 | 21 |
| Stage IV | 77 | 33 | 110 |
| Heregulin positive status and staining in archival tissue(Participants) | Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone | Total |
|---|---|---|---|
| Count of participants | 103 | 49 | 152 |
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Elevation Oncology