Trial · NCT02387216

A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC

NCT02387216, Phase 2, Terminated, Elevation Oncology; results first posted 2021-10-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC. Trials, record NCT02387216. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02387216

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC
NCT number: NCT02387216
Status: Terminated
Phases: Phase 2
Enrollment: 153 participants, actual
Lead sponsor: Elevation Oncology
Conditions: Non-Small Cell Lung Cancer, NSCLC, Adenocarcinoma, Heregulin
Interventions: MM-121, Docetaxel
First posted: 2015-03-12
Last updated: 2021-10-12
Results first posted: 2021-10-12

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression Free Survival	Randomization until progression of disease or death due to any cause within 3 years,11 months (the study terminated prematurely)	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.
Secondary	Overall Survival	From date of randomization until the date of death from any cause assessed upto 3 years,11 months (the study terminated prematurely)	Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause
Secondary	Objective Response Rate	Randomization through end of study up to 3 years, 11 months (the study terminated prematurely)	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
Secondary	Time to Progression	Randomization to date of objective tumor progression up to 3 years, 11 months (the study terminated prematurely)	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.
Secondary	Number of Participants With Treatment-emergent Adverse Events Reported With the Combination of MM-121 With Docetaxel Versus Docetaxel Alone	TEAEs were collected through the study completion (02 Jan 2019), up to 3 years, 11 months	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
Secondary	Pharmacokinetic (PK) Parameters of MM-121 in Combination With Docetaxel and Docetaxel When Given in Combination With MM-121.	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	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.
Secondary	Percentage of Participants With Treatment-emergent Adverse Events Reported With the Combination of MM-121 With Docetaxel Versus Docetaxel Alone	TEAEs were collected through the study completion (02 Jan 2019), up to 3 years, 11 months	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

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression Free Survival	Randomization until progression of disease or death due to any cause within 3 years,11 months (the study terminated prematurely)	The Modified Intent-to-Treat (mITT) Population consisted of all randomized patients who received at least 1 dose of assigned therapy	months	MEDIAN
SECONDARY	Overall Survival	From date of randomization until the date of death from any cause assessed upto 3 years,11 months (the study terminated prematurely)	Modified Intent-to-Treat (ITT) population	months	MEDIAN
SECONDARY	Objective Response Rate	Randomization through end of study up to 3 years, 11 months (the study terminated prematurely)	Modified Intent-to-Treat (ITT) population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Time to Progression	Randomization to date of objective tumor progression up to 3 years, 11 months (the study terminated prematurely)	Modified Intent-to-Treat Population	months	MEDIAN
SECONDARY	Number of Participants With Treatment-emergent Adverse Events Reported With the Combination of MM-121 With Docetaxel Versus Docetaxel Alone	TEAEs were collected through the study completion (02 Jan 2019), up to 3 years, 11 months	Safety Population	participants	NUMBER
SECONDARY	Pharmacokinetic (PK) Parameters of MM-121 in Combination With Docetaxel and Docetaxel When Given in Combination With MM-121.	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	The PK data were not collected for this abbreviated report. There was no pharmacokinetic data feasible for the analysis, and as such, no related analyses were performed. Hence, data could not be reported in the data table.
SECONDARY	Percentage of Participants With Treatment-emergent Adverse Events Reported With the Combination of MM-121 With Docetaxel Versus Docetaxel Alone	TEAEs were collected through the study completion (02 Jan 2019), up to 3 years, 11 months	Safety Population	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group30

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Progression Free Survival	Arm A (Experimental): MM-121 in Combination With Docetaxel		3.4	Inter-Quartile Range 1.9 to 5.7	months
Progression Free Survival	Arm B (Comparator): Docetaxel Alone		4.1	Inter-Quartile Range 2.7 to 6.3	months
Overall Survival	Arm A (Experimental): MM-121 in Combination With Docetaxel		7.7	Inter-Quartile Range 3.6 to 10.4	months
Overall Survival	Arm B (Comparator): Docetaxel Alone		8.4	Inter-Quartile Range 5.8 to 14.7	months
Objective Response Rate	Arm A (Experimental): MM-121 in Combination With Docetaxel	Objective Response	14		Participants
Objective Response Rate	Arm B (Comparator): Docetaxel Alone	Objective Response	2		Participants
Objective Response Rate	Arm A (Experimental): MM-121 in Combination With Docetaxel	Partial Response (PR)	14		Participants
Objective Response Rate	Arm B (Comparator): Docetaxel Alone	Partial Response (PR)	2		Participants
Objective Response Rate	Arm A (Experimental): MM-121 in Combination With Docetaxel	Stable Disease (SD)	39		Participants
Objective Response Rate	Arm B (Comparator): Docetaxel Alone	Stable Disease (SD)	26		Participants

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm A (Experimental): MM-121 in Combination With Docetaxel	103
Overall Study	STARTED	Arm B (Comparator): Docetaxel Alone	49
Overall Study	COMPLETED	Arm A (Experimental): MM-121 in Combination With Docetaxel	3
Overall Study	COMPLETED	Arm B (Comparator): Docetaxel Alone	2
Overall Study	NOT COMPLETED	Arm A (Experimental): MM-121 in Combination With Docetaxel	100
Overall Study	NOT COMPLETED	Arm B (Comparator): Docetaxel Alone	47

Source ClinicalTrials.gov

Adverse events756

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Arm A (Experimental): MM-121 in Combination With Docetaxel	29	103
other	Anaemia	Blood and lymphatic system disorders	Arm B (Comparator): Docetaxel Alone	11	49
other	Neutropenia	Blood and lymphatic system disorders	Arm A (Experimental): MM-121 in Combination With Docetaxel	29	103
other	Neutropenia	Blood and lymphatic system disorders	Arm B (Comparator): Docetaxel Alone	11	49
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm A (Experimental): MM-121 in Combination With Docetaxel	8	103
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm B (Comparator): Docetaxel Alone	6	49
other	Leukopenia	Blood and lymphatic system disorders	Arm A (Experimental): MM-121 in Combination With Docetaxel	6	103
other	Leukopenia	Blood and lymphatic system disorders	Arm B (Comparator): Docetaxel Alone	4	49
other	Lymphopenia	Blood and lymphatic system disorders	Arm A (Experimental): MM-121 in Combination With Docetaxel	1	103
other	Lymphopenia	Blood and lymphatic system disorders	Arm B (Comparator): Docetaxel Alone	0	49

1 to 10 of 756Source ClinicalTrials.gov

See all 756 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A (Experimental): MM-121 in Combination With Docetaxel	64	103
Total, all-cause mortality	Arm B (Comparator): Docetaxel Alone	25	49
Total, other adverse events	Arm A (Experimental): MM-121 in Combination With Docetaxel	103	103
Total, other adverse events	Arm B (Comparator): Docetaxel Alone	47	49
Total, serious adverse events	Arm A (Experimental): MM-121 in Combination With Docetaxel	40	103
Total, serious adverse events	Arm B (Comparator): Docetaxel Alone	15	49

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
30975923	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm A (Experimental): MM-121 in Combination With Docetaxel vs Arm B (Comparator): Docetaxel Alone: deaths from any cause	Trial comparisons
Arm A (Experimental): MM-121 in Combination With Docetaxel vs Arm B (Comparator): Docetaxel Alone: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02387216

GET https://conductscience.org/api/trials/v1/NCT02387216/results?page=2

API reference For AI assistants